Supplemental Nutrition Assistance Program Participation is Associated with Lower Health Care Spending among Working Age Adults without Dependents.

Prior evidence suggests an association among food insecurity, poor health, and increased health care spending. In this study, we are using a natural experiment to confirm if longer participation in the Supplemental Nutrition Assistance Program (SNAP) is associated with reduced Medicaid spending among a highly impoverished group of adults. In 2013, the mandatory work requirements associated with SNAP benefits were lifted for able-bodied adults without dependents (ABAWDs). Using 2013 to 2015 Medicaid and SNAP data of 24,181 Minnesotans aged 18-49, we examined if changes in SNAP enrollment duration affect health care expenditures. In fully adjusted within-participant regression models, for each additional month of SNAP, average annual health care spending was $98.8 lower (95% CI: -131.7, -66.0; p<.001) per person. Our data suggests that allowing ABAWDs to receive SNAP even in months they are not working may be critical to their health as well as cost-effective.

INCIDENCE OF RIFAMPICIN-RESISTANCE PRESUMPTIVE M. TUBERCULOSIS CASES AMONG OUTPATIENTS IN KEBBI STATE, NIGERIA.

BACKGROUND: The present study determined the incidence of rifampicin resistance M. tuberculosis among outpatients at the General Hospital Yauri, Kebbi State, Nigeria. MATERIALS AND METHODS: The study is a cross-sectional study conducted from February 2018 to October 2019. Sociodemographic data were collected from hospital registration books. Rifampicin resistance M. tuberculosis was detected using GeneXpert Model GX-IV following manufacturers' instruction. Descriptive statistics and logistic regression were computed using SPSS version 20. The results were presented as odds ratios with associated 95% confidence intervals, and P-value at 0.05. RESULT: Of the 837 samples, 65.8% (551/837) were males, and 34.2% (286/837) females, 11.4% (95/837) HIV-seropositive. M. tuberculosis was detected in 15.5% (130/837), of which 116/130 (89.23%) were males and 14/130 (10.77%) females. M. tuberculosis-HIV coinfection was detected in 9.47% (9/95) of HIV positive. Rifampicin resistance was observed in 1.3% (11/837), 7.7% (10/130) in M. tuberculosis patients and 1.05% (1/94) in HIV seropositive. In logistic regression, the odds ratio for having a rifampicin-resistant M. tuberculosis was 0.49 (0.15-1.54) for > 30 years; taking <30 years as the reference value, 1.02 (1.00-1.03) for male; taking female as the reference value, and 0.78 (0.09-6.15) for HIV positive, taking negative as the reference value. CONCLUSION: This study reported the current incidence rate of rifampicin-resistant M. tuberculosis at the General Hospital Yelwa Yauri, Kebbi State, Nigeria, among presumptive TB patients. Patients diagnosed with rifampicin-resistant M. tuberculosis were predominantly male adults. Thus, frequent screening is vital for surveillance and reduces the risk of transmission and spread of M. tuberculosis infections.

Nutrition Facts Panel use is associated with diet quality and dietary patterns among Latinos with type 2 diabetes.

OBJECTIVE: The study aims were to (i) identify determinants of Nutrition Facts Panel (NFP) use and (ii) describe the association between NFP use and dietary intake among Latinos with type 2 diabetes. DESIGN: Baseline cross-sectional data from a clinical trial were used to assess the association between NFP use and dietary intake. Diet was measured using two methods: (i) a diet quality score (the Healthy Eating Index-2010) derived from a single 24 h recall and (ii) dietary pattern (exploratory factor analyses) from an FFQ. Multivariable logistic and non-parametric quantile regressions were conducted, as appropriate. Settings Hartford County, Connecticut, USA. SUBJECTS: Latino adults (n 203), ≥21 years of age, with diagnosed type 2 diabetes, glycosylated Hb≥7 %, and without medical conditions limiting physical activity. RESULTS: Participants' education level, diabetes-related knowledge and English speaking were positively associated with NFP use. At the higher percentiles of diet quality score, NFP use was significantly associated with higher diet quality. Similarly, NFP users were more likely to consume a 'healthy' dietary pattern (P=0·003) and less likely to consume a 'fried snack' pattern (P=0·048) compared with NFP non-users. CONCLUSIONS: The association between reported NFP use and diet quality was positive and significantly stronger among participants who reported consuming a healthier diet. While NFP use was associated with a healthier dietary pattern, not using NFP was associated with a less-healthy, fried snack pattern. Longitudinal studies are needed to understand whether improving NFP use could be an effective intervention to improve diet quality among Latinos with type 2 diabetes.

Clinical utility of 99mTc-ubiquicidin (29-41) as an adjunct to bone scan in differentiating infected versus noninfected loosening of prosthesis before revision surgery.

PURPOSE: The aim of this study was to evaluate the utility of Tc-ubiquicidin (Tc-UBI) (29-41) as an adjunct to an methylene diphosphonate (MDP) bone scan in differentiating septic versus aseptic loosening in patients with painful prosthesis posted for revision surgery. PATIENTS AND METHODS: A two-vial cold kit of UBI (29-41) was prepared and utilized for the preparation of patient dose of Tc-UBI (29-41). Twenty two patients with painful hip or knee prosthesis and scheduled for revision surgery were included in the study. Overall, 370-555 MBq of Tc-UBI (29-41) was injected intravenously in all the patients. A blood pool image at 20 min after injection was followed by spot views of the suspected region of infection (target) and a corresponding normal area (nontarget) at 60 min. All patients underwent a routine Tc-MDP three-phase whole-body bone scan, followed by single-photon emission computed tomography/computed tomography of the prosthesis within a week of the Tc-UBI (29-41) study. For Tc-UBI scans, a visual score (0-3) was used to categorize studies as positive or negative, with scores of 0 (minimal or no uptake; less than soft tissue or contralateral extremity) and 1 (mild; equivalent to soft tissue or contralateral extremity) being considered negative and scores of 2 (moderate; uptake greater than soft tissue or contralateral extremity, but less than the liver) or 3 (intense; uptake greater than soft tissue or contralateral extremity and equivalent to the liver) being considered positive. The final correlation was on the basis of bacterial culture as the major criterion and the results of clinical tests, radiography, fluorine-18-fluorodeoxyglucose PET-CT, and three-phase bone scanning as the minor criteria. RESULTS: In all, 22 studies were carried out with Tc-UBI (29-41). Of these, 16 scans were considered positive and six were negative for infection foci. All negative scans were subsequently confirmed to be true negative. Adverse reactions were not observed during image acquisition and within 5 days after the study. The overall sensitivity, specificity, and positive and negative predictive values were 100, 85.7, 93.75, and 100%, respectively. A combination of an MDP bone scan and UBI scans was considered to yield maximum confidence toward reporting for the presence of infection. CONCLUSION: Patient dose of Tc-UBI (29-41) was prepared successfully and a simple quality control method to check radiolabeling yield was used at the hospital radiopharmacy. Tc-UBI (29-41) showed promise in localizing foci of infection, with optimal visualization at 20-60 min, for the evaluation of prosthesis loosening.

Nutrition label use is associated with lower longer-term diabetes risk in US adults.

Background: Regular nutrition label use may have important long-term health implications. To our knowledge, the role of nutrition label use in protecting against the development of chronic diseases was unexplored prospectively before this study.Objective: We tested the association between nutrition label use and risk of a future diabetes diagnosis in a multiethnic US cohort.Design: Data from the ongoing National Longitudinal Survey of Youth-1979 (NLSY79) were analyzed. From 2002 (baseline) to 5 follow-up time points (2004-2012), 7150 diabetes-free, multiethnic young adults were prospectively followed for a diagnosis of incident diabetes. Nutrition label use, diabetes diagnosis, time to diabetes diagnosis, and all covariates were self-reported.Results: Between January 2002 and September 2013, 430 participants (6.0%) were diagnosed with diabetes. A weighted, multivariable, extended Cox regression was conducted, which suggested that in nutrition label users, the HR of diabetes diagnosis risk decreased significantly with time (P-nutrition label use × time interaction < 0.05) compared with risk in nutrition label nonusers.Conclusions: There is an association between nutrition label use and diabetes risk in the longer term. However, additional longitudinal research with a robust dietary intake assessment is needed to test this hypothesis.

Nutrition facts panel use is associated with higher diet quality and lower glycated hemoglobin concentrations in US adults with undiagnosed prediabetes.

BACKGROUND: The majority of US consumers use the nutrition facts panel (NFP) or health claims for food selections. Although previous studies have consistently reported positive impacts of NFP use on dietary intake, evidence regarding the effect of the use of health claims, either alone or in combination with the NFP, on diet quality and health outcomes is scarce. OBJECTIVES: Our primary objective was to test for associations of the use of food labels (the NFP or health claims) with overall diet quality in individuals with prediabetes. In addition, we examined the association between food label use and glycated hemoglobin (HbA1c) concentrations. DESIGN: We conducted a weighted linear regression, which was appropriate for a complex sampling survey, with the use of cross-sectional data from 2654 US adults with undiagnosed prediabetes who participated in the 2005-2010 NHANES cycles. The following 4 categories of food label (NFP or health claims) use were identified: 1) both labels, 2) health claims only, 3) neither label, and 4) the NFP only. Healthy Eating Index-2010 score, which we used to assess diet quality, was calculated from two 24-h recalls. Blood samples for analyzing HbA1c concentrations (glycemic control) were collected in the mobile examination center. RESULTS: The overall diet quality scores for the use of both labels [b: -2.76 (95% CI: -5.04, -0.48); P = 0.019], of health claims only [b: -3.46 (-6.64, -0.28); P = 0.033], and of neither label [b: -4.01 (-5.75, -2.28); P < 0.001] were lower than those of NFP-only users. Moreover, HbA1c concentrations of users of both labels [b: 0.09% (95% CI: 0.03%, 0.16%); P = 0.008] and health claims only [b: 0.13% (95% CI: 0.02%, 0.25%); P = 0.021] were higher than those of NFP-only users. CONCLUSIONS: In participants with undiagnosed prediabetes, the use of health claims alone, of both labels, or of neither label (compared with the use of the NFP only) was associated with poorer diet quality. In addition, users of neither label and users of both labels had poorer glycemic control. Further studies are needed to understand why the use of health claims may not be health promoting in this high-risk population.

Preliminary evaluation of indigenous 90 Y-labelled microspheres for therapy of hepatocellular carcinoma.

BACKGROUND & OBJECTIVES: Yttrium-90 ( 90 Y)-based radioembolization has been employed to treat hepatocellular carcinoma (HCC) as commercial radioactive glass and polymeric resin microspheres. However, in India and other Asian countries, these preparations must be imported and are expensive, validating the need for development of indigenous alternatives. This work was aimed to develop an economically and logistically favourable indigenous alternative to imported radioembolizing agents for HCC therapy. METHODS: The preparation of 90 Y-labelled Biorex 70 microspheres was optimized and in vitro stability was assessed. Hepatic tumour model was generated in Sprague-Dawley rats by orthotopic implantation of N1S1 rat HCC cell line. In vivo localization and retention of the 90 Y-labelled Biorex 70 microspheres was assessed for seven days, and impact on N1S1 tumour growth was studied by histological examination and biochemical assays. RESULTS: Under optimal conditions, >95% 90 Y-labelling yield of Biorex70 resin microspheres was obtained, and these showed excellent in vitro stability of labelling (>95%) at seven days. In animal studies, 90 Y-labelled Biorex 70 microspheres were retained (87.72±1.56% retained in liver at 7 days). Rats administered with 90 Y-labelled Biorex 70 microspheres exhibited lower tumour to liver weight ratio, reduced serum alpha-foetoprotein level and greater damage to tumour tissue as compared to controls. INTERPRETATION & CONCLUSIONS: 90 Y-labelled Biorex 70 microspheres showed stable retention in the liver and therapeutic effect on tumour tissue, indicating the potential for further study towards clinical use.

Weight Gain Prevention among Midlife Women: A Randomized Controlled Trial to Address Needs Related to the Physical and Social Environment.

Women tend to gain weight at midlife (40-60 years) increasing risk of obesity-related chronic diseases. Within specific eating occasions, needs related to the physical and social environment may result in less healthy eating behavior, which can lead to weight gain over time. The purpose of this study was to determine if a dietitian-delivered nutrition counseling intervention tailored to eating occasion needs could improve diet and prevent weight gain among midlife women over two years. A randomized controlled trial was conducted with healthy midlife women (n = 354) in one U.S. metropolitan area. The intervention group (n = 185) received ten hours of individual nutrition counseling from dietitians over six months, while women in a control group (n = 169) received no counseling. Measured height, weight and waist circumference, and dietary intakes were collected at baseline and every six months over two years. Mixed linear models were used to test for intervention effect on change in outcome variables over time. Dietary intakes of fruit, reduced/low-fat dairy foods and refined grains were significantly improved over time in the intervention compared to control group. However, the intervention had no effect on weight over time (p = 0.48). Nutrition counseling tailored to address eating occasion needs improved self-reported diet but did not significantly affect weight change.

Effects of Food Label Use on Diet Quality and Glycemic Control Among Latinos With Type 2 Diabetes in a Community Health Worker-Supported Intervention.

OBJECTIVES: To determine the impact of an intervention led by community health workers (CHWs) on food label use and to assess whether food label use and diet quality mediate the intervention's impact on glycemic control. METHODS: From 2006 to 2010, 203 Latinos (intervention group, n = 100; control group, n = 103) in Hartford County, Connecticut, with type 2 diabetes were randomized to an intervention that included 17 CHW-led home-based sessions over a 12-month period in addition to the standard of care available in both study arms. Data on food label use, diet quality, covariates, and glycated hemoglobin (HbA1c) were collected at baseline and at 3, 6, 12, and 18 months. Data were analyzed via mixed effects and multilevel structural equation modeling. RESULTS: Food label use in the intervention (vs control) group was significantly higher at 3, 12, and 18 months (odds ratio = 2.99; 95% confidence interval = 1.69, 5.29). Food label use and diet quality were positive mediators of improved HbA1c levels. CONCLUSIONS: Culturally tailored interventions led by CHWs could increase food label use. Also, CHW-delivered food label education may lead to better diet quality and improve glycemic control among Latinos with type 2 diabetes.

Preparation & in vitro evaluation of 9°Y-DOTA-rituximab.

BACKGROUND & OBJECTIVES: Radioimmunotherapy is extensively being used for the treatment of non-Hodgkin's lymphoma (NHL). Use of rituximab, a chimeric anti-CD20 antibody directed against the CD20 antigen in combination with suitable beta emitters is expected to result in good treatment response by its cross-fire and bystander effects. The present work involves the conjugation of p-isothiocyanatobenzyl DOTA (p-SCN-Bn-DOTA) to rituximab, its radiolabelling with [90] Y and in vitro and in vivo evaluation to determine its potential as a radioimmunotherapeutic agent. METHODS: Rituximab was conjugated with p-SCN-Bn-DOTA at 1:1 antibody: DOTA molar ratio. The number of DOTA molecules linked to one molecule of rituximab was determined by radioassay and spectroscopic assay. Radiolabelling of rituximab with 90 Y was carried out and its in vitro stability was evaluated. In vitro cell binding studies were carried out in Raji cells expressing CD20 antigen. Biodistribution studies were carried out in normal Swiss mice. RESULTS: Using both radioassay and spectroscopic method, it was determined that about five molecules of DOTA were linked to rituximab. Radiolabelling of the rituximab conjugate with [90] Y and subsequent purification on PD-10 column gave a product with radiochemical purity (RCP) > 98 per cent which was retained at > 90 per cent up to 72 h when stored at 37°C. In vitro cell binding experiments of 90 Y-DOTA-rituximab with Raji cells exhibited specific binding of 20.7 ± 0.1 per cent with [90] Y-DOTA-rituximab which reduced to 15.5 ± 0.2 per cent when incubated with cold rituximab. The equilibrium constant K d for 90 Y-DOTA-Rituximab was determined to be 3.38 nM. Radiolabelled antibody showed clearance via hepatobiliary and renal routes and activity in tibia was found to be quite low indicating in vivo stability of [90] Y-DOTA-rituximab. INTERPRETATION & CONCLUSIONS: p-SCN-Bn-DOTA was conjugated with rituximab and radiolabelling with 90 Y was carried out. In vitro studies carried out in Raji cells showed the specificity of the radiolabelled conjugate suggesting the potential uitability of the formulation as a radiopharmaceutical for therapy of NHL.

Relevance of radiobiological concepts in radionuclide therapy of cancer.

PURPOSE: Radionuclide therapy (RNT) is a rapidly growing area of clinical nuclear medicine, wherein radionuclides are employed to deliver cytotoxic dose of radiation to the diseased cells/tissues. During RNT, radionuclides are either directly administered or delivered through biomolecules targeting the diseased site. RNT has been clinically used for diverse range of diseases including cancer, which is the focus of the review. CONCLUSIONS: The major emphasis in RNT has so far been given towards developing peptides/antibodies and other molecules to conjugate a variety of therapeutic radioisotopes for improved targeting/delivery of radiation dose to the tumor cells. Despite that, many of the RNT approaches have not achieved their desired therapeutic success probably due to poor knowledge about complex and dynamic (i) fate of radiolabeled molecules; (ii) radiation dose delivered; (iii) cellular heterogeneity in tumor mass; and (iv) cellular radiobiological response. Based on understanding gathered during recent years, it may be stated that besides the absorbed dose, the net radiobiological response of tumor/normal cells also determines the clinical response of radiotherapeutic modalities including RNT. The radiosensitivity of tumor/normal cells is governed by radiobiological phenomenon such as radiation-induced bystander effect, genomic instability, adaptive response and low dose hyper-radiosensitivity. These concepts have been well investigated in the context of external beam radiotherapy, but their clinical implications during RNT have received meagre attention. In this direction, a few studies performed using in vitro and in vivo models envisage the possibilities of exploiting the radiobiological knowledge for improved therapeutic outcome of RNT.

Studies on batch formulation of a kit for the preparation of the 99mTc-Ubiquicidin (29-41): An infection imaging agent.

The aim of this study was to formulate an indigenous cold kit of Ubiquicidin, UBI (29-41), for easy preparation of (99m)Tc-UBI (29-41) to be used as an infection imaging agent. A two component kit with the peptide and SnCl2 as vial 1 and optimum amount of NaOH as vial 2 was successfully formulated as seen from the consistent radiochemical and pharmaceutical purity of the product over six consecutive batches of kits. The utility of the kit could be demonstrated through in-vitro and in vivo specificity of (99m)Tc-UBI (29-41).

Preliminary evaluation of the potential of 99mTc carbonyl-DTPA-Rituximab as a tracer for sentinel lymph node detection.

Preliminary work with (99m)Tc carbonyl-DTPA-Rituximab was attempted to test its feasibility as a sentinel lymph node (SLN) tracer for patients with breast cancer. (99m)Tc labeling of DTPA-Rituximab conjugate was carried out via (99m)Tc carbonyl synthon which exhibited >95% radiochemical purity and good in vitro stability. In vitro studies of (99m)Tc carbonyl-DTPA-Rituximab in normal and malignant B cells showed higher binding in malignant cells. In vivo distribution of (99m)Tc carbonyl-DTPA-Rituximab in Wistar rat footpad model indicated good retention by B-cells present in the sentinel lymph node.

(68) Ga-labeled Ciprofloxacin Conjugates as Radiotracers for Targeting Bacterial Infection.

With an aim of developing a bacteria-specific molecular imaging agent, ciprofloxacin has been modified with a propylamine spacer and linked to two common bifunctional chelators, p-SCN-Bz-DOTA and p-SCN-Bz-NOTA. The two ciprofloxacin conjugates, CP-PA-SCN-Bz-DOTA (1) and CP-PA-SCN-Bz-NOTA (2), were radiolabeled with (68)Ga in >90% radiochemical yield and were moderately stable in vitro for 4 h. The efficacy of (68)Ga-1 and (68)Ga-2 has been investigated in vitro in Staphylococcus aureus cells where bacterial binding of the radiotracers (0.9-1.0% for (68)Ga-1 and 1.6-2.3% for (68)Ga-2) could not be blocked in the presence of excess amount of unlabeled ciprofloxacin. However, uptake of radiotracers in live bacterial cells was significantly higher (p < 0.01) than that in non-viable bacterial cells. Bacterial infection targeting efficacy of (68)Ga-1 and (68)Ga-2 was tested in vivo in rats where the infected muscle-to-inflamed muscle ((68)Ga-1: 2 ± 0.2, (68)Ga-2: 3 ± 0.5) and infected muscle-to-normal muscle ratios ((68)Ga-1: 3 ± 0.4, (68)Ga-2: 6.6 ± 0.8) were found to improve at 120 min p.i. Fast blood clearance and renal excretion was observed for both the radiotracers. The two (68)Ga-labeled infection targeting radiotracers could discriminate between bacterial infection and inflammation in vivo and are worthy of further detailed investigation as infection imaging agents at the clinical level.

Synthesis and Preclinical Evaluation of (177)Lu-CHX-A"-DTPA-Rituximab as a Radioimmunotherapeutic Agent for Non-Hodgkin's Lymphoma.

INTRODUCTION: Radioimmunotherapy is a feasible treatment modality for B-cell lymphomas expressing CD20 antigen. Tagging of anti-CD20 monoclonal antibody with a ß(-) emitter will deliver radiation to the tumor preferentially, thereby causing its destruction. This work explores the utility of (177)Lu-CHX-A"-DTPA-Rituximab as a radioimmunotherapeutic agent for non-Hodgkin's lymphoma (NHL). METHODS: Rituximab was conjugated with p-NCS-Bn-CHX-A"-DTPA and radiolabeled with (177)Lu. (177)Lu-CHX-A"-DTPA-Rituximab was characterized by SE-HPLC. In vitro cell binding and inhibition studies were carried out in Raji cells which express CD20 antigen. Biodistribution studies were performed in SCID mice bearing lymphoma at various time intervals. RESULTS: The CHX-A"-DTPA-Rituximab conjugate prepared had three molecules of DTPA per Rituximab molecule. Radiochemical purity of (177)Lu-CHX-A"-DTPA-Rituximab was >95%. In the HPLC system, (177)Lu-CHX-A"-DTPA-Rituximab showed a single peak (Rt ∼15.5 minutes). In vitro cell binding studies showed 38.9%±1.1% binding of (177)Lu-CHX-A"-DTPA-Rituximab (∼6.7 nM of radioimmunoconjugate) with Raji cells which reduced to 17.7%±0.5% with the addition of 67 nM of cold antibody. Biodistribution studies showed good tumor uptake at all the time points studied. CONCLUSIONS: In vitro and in vivo studies showed good specificity of (177)Lu-CHX-A"-DTPA-Rituximab toward CD20 antigen. It can be concluded that (177)Lu-CHX-A"-DTPA-Rituximab could be a promising agent in the treatment of NHL.

Utility of (99m)Tc-Hynic-TOC in 131I Whole-Body Scan Negative Thyroid Cancer Patients with Elevated Serum Thyroglobulin Levels.

Several studies have reported on the expression of somatostatin receptors (SSTRs) in patients with differentiated thyroid cancer (DTC). The aim of this study was to evaluate the imaging abilities of a recently developed Technetium-99m labeled somatostatin analog, (99m)Tc-Hynic-TOC, in terms of precise localization of the disease. The study population consisted of 28 patients (16 men, 12 women; age range: 39-72 years) with histologically confirmed DTC, who presented with recurrent or persistent disease as indicated by elevated serum thyroglobulin (Tg) levels after initial treatment (serum Tg > 10 ng/ml off T4 suppression for 4-6 weeks). All patients were negative on the Iodine-131 posttherapy whole-body scans. Fluorine-18 fluorodeoxyglucose positron emission tomography ((18)F-FDG PET) was performed in all patients. SSTR scintigraphy was true positive in 23 cases (82.1%), true negative in two cases (7.1%) and false negative in three cases (10.7%) which resulted in a sensitivity of 88.46%, specificity of 100% and an accuracy of 89.2%. Sensitivity of (99m)Tc-Hynic-TOC scan was higher (93.7%) for patients with advanced stages, that is stages III and IV. (18)F-FDG showed a sensitivity of 93.7%, a specificity of 50% and an accuracy of 89.3%. (18)F-FDG PET was found to be more sensitive, with lower specificity due to false positive results in 2 patients. Analysis on a lesion basis demonstrated substantial agreement between the two imaging techniques with a Cohen's kappa of 0.66. Scintigraphy with (99m)Tc-Hynic-TOC might be a promising tool for treatment planning; it is easy to perform and showed sufficient accuracy for localization diagnostics in thyroid cancer patients with recurrent or metastatic disease.

An indigenous single-vial kit formulation of human serum albumin nanocolloid for use in sentinel lymph node detection.

OBJECTIVE: In-situ sentinel lymph node (SLN) detection is an important component in staging cancers of various origins. At present, technetium-99m (Tc)-labeled nanoparticle formulations like sulfur colloid and human serum albumin (HSA) nanocolloid are used in the clinic as SLN tracers. In India, HSA nanocolloid cold kits have so far been imported. This study aims to develop and evaluate an indigenous alternative to imported HSA nanocolloid cold kits for SLN detection/imaging. MATERIALS AND METHODS: Production of cold kits was standardized and the product was characterized for its suitability in terms of particle size. Tc-labeling of an in-house HSA nanocolloid was optimized, and the yield and stability of the product were assessed. Animal studies were performed in Wistar rats using the footpad model. Clinical evaluation was performed in 54 patients using a combination of scintigraphic imaging and a hand-held gamma probe. RESULTS AND CONCLUSION: With the optimized protocol, HSA nanocolloids with particle sizes ranging from 50 to 200 nm were obtained. Greater than 90% Tc-labeling yield was obtained in 15 min reactions, and the radiopharmaceutical was stable for up to 24 h after preparation. The animal studies showed similar SLN uptake and improved retention pattern compared with those of the imported Nanocoll radiopharmaceutical. Clinical studies showed detectable 'hot' nodes in 53 of 54 patients, demonstrating sensitivity of the product for clinical utility. In conclusion, this indigenous HSA nanocolloid cold kit is proposed as a logistically favorable alternative to imported kits for SLN detection in the Indian clinical scenario.

(131)I-Nimotuzumab - A potential radioimmunotherapeutic agent in treatment of tumors expressing EGFR.

The anti-EGFR antibody Nimotuzumab was radioiodinated with I-131 by Chloramine T and Iodogen methods. The (131)I-Nimotuzumab was purified and characterized by HPLC. Purified (131)I-Nimotuzumab exhibited radiochemical purity of >95% and retained good in vitro stability upto 24h at room temperature by both the methods. Cell binding studies carried out in A431 cells expressing EGF receptors showed good immunoreactivity of the product upto 5 days post radioiodination. Biodistribution studies in normal Swiss mice showed fast clearance by both renal and gastrointestinal routes with minimal thyroid uptake.

Single vial kit formulation of DOTATATE for preparation of (177) Lu-labeled therapeutic radiopharmaceutical at hospital radiopharmacy.

The clinical applications of radiolabeled somatostatin analogue (177) Lu-DOTA-Tyr(3) -Thr(8) -Octreotide ((177) Lu-DOTATATE) constitute a promising treatment option for patients with disseminated and inoperable neuroendocrine (NET) tumors. Formulation of (177) Lu-DOTATATE in hospital radiopharmacy under aseptic conditions in a safe and reliable manner is a major constraint for its extensive use. The present work was intended to develop a kit for the safe preparation of the therapeutic radiopharmaceutical, viz. (177) Lu-DOTATATE of high quality that can be easily adapted at conventional hospital radiopharmacies. Single vial kits of DOTATATE were formulated and evaluated for suitability for radiolabeling as well as stability on its storage. Patient dose of (177) Lu-DOTATATE (7.4 GBq) could be successfully prepared using semi-automated in-house setup that assures safe handling and high yields of product of pharmaceutical purity suitable for clinical use. Fast clearance of activity via renal route was observed in preclinical biodistribution studies of (177) Lu-DOTATATE carried out in normal Swiss mice. Deployment of in-house produced (177) LuCl3 , cold kits and easy adaptability of synthesis setup at hospital radiopharmacy for preparation is likely to expand applications of peptide receptor radionuclide therapy.

Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial.

OBJECTIVE: Latinos with type 2 diabetes (T2D) face major healthcare access and disease management disparities. We examined the impact of the Diabetes Among Latinos Best Practices Trial (DIALBEST), a community health worker (CHW)-led structured intervention for improving glycemic control among Latinos with T2D. RESEARCH DESIGN AND METHODS: A total of 211 adult Latinos with poorly controlled T2D were randomly assigned to a standard of healthcare (n = 106) or CHW (n = 105) group. The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period. Sessions addressed T2D complications, healthy lifestyles, nutrition, healthy food choices and diet for diabetes, blood glucose self-monitoring, and medication adherence. Demographic, socioeconomic, lifestyle, anthropometric, and biomarker (HbA1c, fasting blood glucose, and lipid profile) data were collected at baseline and 3, 6, 12, and 18 months (6 months postintervention). Groups were equivalent at baseline. RESULTS: Participants had high HbA1c at baseline (mean 9.58% [81.2 mmol/mol]). Relative to participants in the control group, CHWs had a positive impact on net HbA1c improvements at 3 months (-0.42% [-4.62 mmol/mol]), 6 months (-0.47% [-5.10 mmol/mol]), 12 months (-0.57% [-6.18 mmol/mol]), and 18 months (-0.55% [-6.01 mmol/mol]). The overall repeated-measures group effect was statistically significant (mean difference -0.51% [-5.57 mmol/mol], 95% CI -0.83, -0.19% [-9.11, -2.03 mmol/mol], P = 0.002). CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the 12- and 18-month visits. There was no significant effect on blood lipid levels, hypertension, and weight. CONCLUSIONS: DIALBEST is an effective intervention for improving blood glucose control among Latinos with T2D.