18F-sodium fluoride PET/CT provides prognostic clarity compared to calcium and Framingham risk scoring when addressing whole-heart arterial calcification.

AIMS: To investigate the benefit of utilizing 18F-sodium fluoride (NaF) PET/CT over calcium and Framingham scoring for potential preventative coronary artery disease (CAD) intervention. METHODS AND RESULTS: This retrospective study included 136 participants (ages 21-75, BMI 18-43 kg/m2): 86 healthy controls and 50 patients. CT heart segmentations were superimposed onto PET images and standard uptake values (SUV) were calculated by a semi-auto segmentation method of drawing volumes of interest around the heart. Intergroup comparisons were made matching 37 patient/control pairs based on age, gender, and BMI. ROC curves were generated to determine how well SUV and Framingham methods predicted patient status. Regressions including all 136 participants were performed between SUV, age, and BMI. Patients exhibited higher average SUV (SUVmean; P = 0.006) and Framingham scores (P = 0.02) than controls. However, ROC curves indicated that SUVmean could discriminate patients from controls (AUC = 0.63, P = 0.049), but Framingham scores could not (AUC = 0.44, P = 0.38). Calcium scores and maximum SUV (SUVmax) did not differ between patients and controls. SUVmean correlated with age and BMI among females (age, partial R2 = 0.16, P = 0.001; BMI, partial R2 = 0.12, P = 0.004) and males (age, partial R2 = 0.28, P < 0.0001; BMI, partial R2 = 0.22, P < 0.0001). CONCLUSION: Unlike calcium scores, NaF PET/CT-derived values differed between patients and controls. Framingham risk score patterns echoed those of SUVmean, but were not sensitive enough to predict patient status. SUVmean values increased with age and BMI. Therefore, incorporation of NaF PET/CT into routine prognostic CAD assessment might prove beneficial for assessing early stage plaque calcification in coronary arteries. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01724749).

Optimizing Regulatory Reviews for Clinical Protocols that Use Radiopharmaceuticals: Findings of the University of Pennsylvania Radiation Research Safety Committee.

ABSTRACT: Institutional radiation safety committees review research studies with radiation exposure. However, ensuring that the potential patient benefit and knowledge gained merit the radiation risks involved often necessitates revisions that inadvertently delay protocol activations. This quality-improvement study analyzed protocols, identified factors associated with approval time by a radiation safety committee, and developed guidelines to expedite reviews without compromising quality. Clinical protocols submitted to the University of Pennsylvania's Radiation Research Safety Committee (RRSC) for review between 2017 and 2021 were studied. Protocol characteristics, review outcome, stipulations, and approval times were summarized. Statistical analysis (Spearman's rho) was used to investigate stipulations and approval time; rank-sum analysis (Kruskal-Wallis or Wilcoxon) was used to determine whether approval time differed by protocol characteristics. One hundred ten (110) protocols were analyzed. Approximately two-thirds of protocols used approved radiopharmaceuticals to aid investigational therapy trials. Twenty-three percent (23%) of protocols received RRSC approval, and 73% had approval withheld with stipulations, which included requests for edits or additional information. Submissions had a median of three stipulations. Median and mean RRSC approval times were 62 and 80.1 d, and 41% of protocols received RRSC approval after IRB approval. RRSC approval time was positively correlated with stipulations (Spearman's rho = 0. 632, p < 0.001). RRSC approval time was longer for studies using investigational new drugs (median 80 d) than approved radiopharmaceuticals (median 57 d, p = 0.05). The review process is lengthy and may benefit from changes, including publishing standardized radiation safety language and commonly required documents and encouraging timely response to stipulations.

Breast Reconstruction Complications After Postmastectomy Proton Radiation Therapy for Breast Cancer.

Purpose: Our purpose was to report complications requiring surgical intervention among patients treated with postmastectomy proton radiation therapy (PMPRT) for breast cancer in the setting of breast reconstruction (BR). Methods and Materials: Patients enrolled on a prospective proton registry who underwent BR with immediate autologous flap, tissue expander (TE), or implant in place during PMPRT (50/50.4 Gy +/- chest wall boost) were eligible. Major reconstruction complication (MRC) was defined as a complication requiring surgical intervention. Absolute reconstruction failure was an MRC requiring surgical removal of BR. A routine revision (RR) was a plastic surgery refining cosmesis of the BR. Kaplan-Meier method was used to assess disease outcomes and MRC. Cox regression was used to assess predictors of MRC. Results: Seventy-three courses of PMPRT were delivered to 68 women with BR between 2013 and 2021. Median follow-up was 42.1 months. Median age was 47 years. Fifty-six (76.7%) courses used pencil beam scanning PMPRT. Of 73 BR, 29 were flaps (39.7%), 30 implants (41.1%), and 14 TE (19.2%) at time of irradiation. There were 20 (27.4%) RR. There were 9 (12.3%) MRC among 5 implants, 2 flaps, and 2 TE, occurring a median of 29 months from PMPRT start. Three-year freedom from MRC was 86.9%. Three (4.1%) of the MRC were absolute reconstruction failure. Complications leading to MRC included capsular contracture in 5, fat necrosis in 2, and infection in 2. On univariable analysis, BR type, boost, proton technique, age, and smoking status were not associated with MRC, whereas higher body mass index trended toward significance (hazard ratio, 1.07; 95% CI, 0.99-1.16; P = .10). Conclusions: Patients undergoing PMPRT to BR had a 12.3% incidence of major complications leading to surgical intervention, and total loss of BR was rare. MRC rates were similar among reconstruction types. Minor surgery for RR is common in our practice.

Factors Associated With Travel Distance in the Receipt of Proton Breast Radiation Therapy.

Introduction: Proton radiation therapy (PBT) may reduce cardiac doses in breast cancer treatment. Limited availability of proton facilities could require significant travel distances. This study assessed factors associated with travel distances for breast PBT. Materials and Methods: Patients receiving breast PBT at the University of Pennsylvania from 2010 to 2021 were identified. Demographic, cancer, and treatment characteristics were summarized. Straight-line travel distances from the department to patients' addresses were calculated using BatchGeo. Median and mean travel distances were reported. Given non-normality of distribution of travel distances, Wilcoxon rank sum or Kruskal-Wallis test was used to determine whether travel distances differed by race, clinical trial participation, disease laterality, recurrence, and prior radiation. Results: Of 1 male and 284 female patients, 67.8% were White and 21.7% Black. Median travel distance was 13.5 miles with interquartile range of 6.1 to 24.8 miles, and mean travel distance was 13.5 miles with standard deviation of 261.4 miles. 81.1% of patients traveled less than 30 and 6.0% more than 100 miles. Black patients' travel distances were significantly shorter than White patients' and non-Black or non-White patients' travel distances (median = 4.5, 16.5, and 11.3 miles, respectively; P < .0001). Patients not on clinical trials traveled more those on clinical trials (median = 14.7 and 10.2 miles, respectively; P = .032). There was no difference found between travel distances of patients with left-sided versus right-sided versus bilateral disease (P = .175), with versus without recurrent disease (P = .057), or with versus without prior radiation (P = .23). Conclusion: This study described travel distances and demographic and clinicopathologic characteristics of patients receiving breast PBT at the University of Pennsylvania. Black patients traveled less than White and non-Black or non-White patients and comprised a small portion of the cohort, suggesting barriers to travel and PBT. Patients did not travel further to receive PBT for left-sided or recurrent disease.

Effect of COVID-19 on Gynecologic Oncology Care: A Survey of Practicing Gynecologic Radiation Oncologists in the United States.

Purpose: The COVID-19 pandemic has placed demands and limitations on the delivery of health care. We sought to assess the effect of COVID-19 on the delivery of gynecologic oncologic care from the perspective of practicing radiation oncologists in the United States. Methods and Materials: An anonymous online survey was created and distributed to preidentified radiation oncologists in the United States with clinical expertise in the management of gynecologic patients. The survey consisted of demographic questions followed by directed questions to assess specific patterns of care related to the COVID-19 pandemic. Results: A total of 47 of 96 invited radiation oncologists responded to the survey for a response rate of 49%. Fifty-six percent of respondents reported an increase in locally advanced cervical cancer with no similar increase for endometrial, vulvar, or vaginal patients. Most respondents (66%) reported a pause in surgical management, with a duration of 1 to 3 months being most common (61%). There was a reported increased use of shorter brachytherapy regimens during the pandemic. Most providers (61%) reported caring for at least 1 patient with a positive COVID-19 test. A pause or delay in treatment due to COVID-19 positivity was reported by 45% of respondents, with 55% reporting that patients chose to delay their own care because of COVID-19-related concerns. Total treatment times >8 weeks for patients with cervical cancer were observed by 33% of respondents, but occurred in >25% of patients. Conclusions: Data from this prospectively collected anonymous survey of practice patterns among radiation oncologists reveal that the COVID-19 pandemic resulted in delays initiating care, truncated brachytherapy treatment courses, and a reported increase in locally advanced cervical cancer cases at presentation. These data can be used as a means of self-assessment to ensure appropriate decision making for gynecologic patients during the endemic phase of COVID-19.

Nursing Telemedicine Educational Encounters: Improved Patient Satisfaction in Radiation Therapy Clinics.

BACKGROUND: Nurse-led education can improve patient satisfaction, and telemedicine has increased patient access during the COVID-19 pandemic. OBJECTIVES: The aim of this article was to investigate how nursing telemedicine educational visits influence patient satisfaction. METHODS: Patients receiving standard of care in-person education for breast cancer radiation therapy (RT) between January 2019 and June 2019 comprised the preintervention cohort. After July 2019, patients received the same information virtually and represented the postintervention cohort. Press Ganey surveys were used to evaluate patient satisfaction, t tests were performed to differentiate satisfaction scores, and f tests were calculated to determine differences in the variances of response. FINDINGS: Patient satisfaction increased in the postintervention cohort for what to expect during RT, how to manage side effects, and nurses' attentiveness to patient questions and worries. There was decreased variance in patient satisfaction in the postintervention group for quality of care received from nurses and caring manner of nurses.

Assessment of femoral neck bone metabolism using 18F-sodium fluoride PET/CT imaging.

BACKGROUND: Standard of care metabolic bone disease assessment relies on changes to bone quantity, which can only be detected after structural changes occur. PURPOSE: To investigate the usefulness of Bone Metabolism Score (BMS), derived from fluorine 18 labeled sodium fluoride (18F-NaF) PET/CT imaging as a biomarker of localized metabolic changes at the femoral neck. METHODS: In this retrospective study, 139 participants (68 females and 71 males, ages 21-75 years) that had undergone 18F-NaF PET/CT were included. BMS was calculated as the ratio of standard uptake value (SUV) in the bone region to that of the total region. Correlations and linear regressions of BMS with age, CT-derived bone mineral density (BMD), body mass index (BMI), height, and weight were conducted. Differences in BMS between women younger and older than the age of 50 years were assessed. Inter- and intra-operator reproducibility was evaluated by coefficient of variation (CV) and intra-class correlation coefficient (ICC). RESULTS: Among females, age was negatively correlated with left and right whole BMS (5.61% and 4.90% drop in BMS per decade of life) and left and right cortical BMS (10.50% and 10.09% drop in BMS per decade of life). BMS of women older than 50 years was lower than BMS of women younger than 50 years (P < .0001). Among males, age was negatively correlated with left and right whole BMS (4.29% and 4.25% drop in BMS per decade of life) and left and right cortical BMS (9.13% and 10.30% drop in BMS per decade of life). BMD was positively correlated with whole (r = 0.80, P < .0001) and cortical (r = 0.92, P < .0001) BMS. CONCLUSIONS: BMS could provide functional insight regarding bone metabolism in the femoral neck to complement bone health status assessed through conventional structural imaging. The methodology described herein could be potentially useful for assessing hip fracture risk in individuals when BMD tests provide borderline determination of bone disease.

Diagnosis and Monitoring of Osteoporosis With 18F-Sodium Fluoride PET: An Unavoidable Path for the Foreseeable Future.

The prevalence of metabolic bone diseases particularly osteoporosis and its precursor, osteopenia, continue to grow as serious global health issues today. On a worldwide perspective, 200million people suffer from osteoporosis and in 2005, over 2million fracture incidents were estimated due to osteoporosis in the United States. Currently, osteoporosis and other metabolic bone diseases are evaluated primarily through dual energy X-ray absorptiometry, and rarely by bone biopsy with tetracycline labeling or Technetium-99m (99mTc) based bone scintigraphy. Deficiencies in these methods have prompted the use of more precise methods of assessment. This review highlights the use of 18F-sodium fluoride (NaF) with PET (NaF-PET), NaF-PET/CT, or NaF-PET/MRI in the evaluation of osteoporosis and osteopenia in the lumbar spine and hip. This imaging modality provides a molecular perspective with respect to the underlying metabolic alterations that lead to osseous disorders by measuring bone turnover through standardized uptake values. Its sensitivity and ability to examine the entire skeletal system make it a more superior imaging modality compared to standard structural imaging techniques. Further research is needed to determine its accuracy in reflecting the efficacy of therapeutic interventions in metabolic bone diseases.