Quality of Care for Cervical and Endometrial Cancer Patients: The Impact of Different Techniques of Sentinel Lymph Node Mapping on Patient Satisfaction.

OBJECTIVES: The purpose of this study was to assess the quality of care in patients who underwent sentinel lymph node (SLN) mapping for endometrial and cervical cancer staging, and evaluate the impact of different techniques on patient satisfaction, i.e. radiotracer Tc99m versus indocyanine green (ICG) or methylene blue injection. METHOD: Women with preoperative stage I endometrial cancer or stage I (1A2-1B1) cervical cancer who underwent surgical staging, including SLN mapping, were considered for this study. Patient satisfaction was assessed using the European Organisation for Research and Treatment of Cancer IN-PATSAT32 questionnaire. Women were classified into two groups according to the different nodal mapping techniques: intracervical preoperative injection of Tc99m nanocolloid + intraoperative blue dye (Group 1) versus intraoperative cervical injection of ICG or blue dye (Group 2). Differences in patient satisfaction scores between the groups were analyzed. RESULTS: Of the 178 eligible women, 143 were included in the study (endometrial cancer n = 106, cervical cancer n = 37): 57 underwent SLN mapping with Tc99m and blue dye (Group 1), and 86 women were mapped intraoperatively with blue dye alone or ICG (Group 2). Analysis of IN-PATSAT32 questionnaire scores showed a higher patient satisfaction score for patients in Group 2 (p = 0.001), which was independent of the physician and surgical outcomes evaluated. The scores were statistically better for Group 2, and also in rating doctors (p = 0.0001), nurses (p = 0.006), and care and services organizations (p = 0.001). CONCLUSIONS: Cervical and endometrial cancer patients who underwent SLN mapping by ICG or blue dye perceived a better quality of care when compared with those patients who underwent the combined radiocolloid and blue dye technique.

Integration of hybrid single-photon emission computed tomography/computed tomography in the preoperative assessment of sentinel node in patients with cervical and endometrial cancer: our experience and literature review.

OBJECTIVE: The purpose of this study was to assess whether there is an additional value of single-photon emission computed tomography/computed tomography (SPECT/CT) over lymphoscintigraphy (LSG) alone for sentinel node (SN) mapping in endometrial and cervical cancer. METHODS: Ten women with clinically cervical stage IA2 to stage IB1 and 25 women with stage I endometrial cancer underwent preoperative LSG for SN mapping. Technetium Tc 99m albumin nanocolloid was injected submucosally at 4 points of the cervix. Patients underwent SPECT/CT emission-transmission study at least 3 hours after standard planar images. Methylene blue was injected into the cervix just before surgery under general anesthesia. All patients underwent hysterectomy, bilateral salpingo-oophorectomy, and radical regional nodal dissection. Hot and/or blue nodes were labeled as SNs. RESULTS: Conventional planar imaging detection rate was 50%, whereas the detection rate of at least one SN with SPECT/CT was 91% (32/35); bilateral detection was achieved in 7 (39%) of 18 women in planar and in 17 (53%) of 32 women in SPECT/CT imaging, respectively. Bilateral detection was achieved in 57% of women (20/35). Sentinel nodes were located in external and internal iliac nodes (66%), obturator nodes (5%), internal iliac nodes (11%), common iliac nodes (9%), and presacral nodes (9%). Lymph node involvement was identified in 5 patients (14%). Sentinel node correctly predicted lymph node involvement in all node-positive patients. Sentinel node sensitivity and negative predictive value of SPECT/CT were 100%. CONCLUSIONS: Single photon emission computed tomography/computed tomography seems to improve intraoperative identification of SNs and provides additional useful information about the anatomic location of SNs compared to planar LSG in cervical and endometrial cancer.

Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived CD133+ cells in ischemic refractory cardiomyopathy trial (RECARDIO).

BACKGROUND: Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product CD133+ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. METHODS: In the phase I "Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy" (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. RESULTS: Patients were treated safely with a mean number of 6.57 ± 3.45 ×  106 ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = - 0.79, p = 0.01) and IL-6 (r = - 0.76, p = 0.02). CONCLUSION: Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02059681 . Registered 11 February 2014.

Sentinel-node mapping in endometrial cancer patients: comparing SPECT/CT, gamma-probe and dye.

OBJECTIVE: The aim of this study was to compare preoperative SPECT/CT with gamma-probe and methylene blue-dye (MBD) in the identification of sentinel lymph node (SLN) in early stage endometrial cancer. METHODS: 40 stage-I EC patients (66.7 ± 9.7 years) underwent preoperative lymphoscintigraphy. After about 3 h from Tc-99m-albumin nanocolloid cervical injection, all patients underwent SPECT/CT study. MBD was injected into the cervix just before surgery under general anesthesia. All patients underwent SLN biopsy, hysterectomy, bilateral salpingo-oophorectomy, and radical regional lymphadenectomy. SPECT/CT findings were compared to those of gamma-probe and MBD techniques. RESULTS: In 2 patients no nodal migration was observed, neither with MBD nor radiotracer. Detection rate of at least one SLN was 90% (36/40 patients) with SPECT/CT, 88% (35/40) intra-operatively with gamma-probe and 80% (32/40) with MBD. Only in 7/40 patients a bilateral migration was obtained with all considered modalities. In particular, bilateral detection was achieved in 26 patients with SPECT/CT, in 24 with gamma-probe and in 10 patients with MBD. The concordance site between SPECT/CT and intraoperative gamma-probe was 73% (29/40 patients: 2 without migration, 21 bilateral and 6 monolateral SLNs); while concordance site with MBD was found in 40% (16/40: 8 bilateral, 6 monolateral SLNs, 2 without SLNs). Overall, 628 LNs were dissected (mean 18 LNs per patient). The median number of SLNs removed was 2 (mean 2.5 per patient). Out of 91 SLNs: 43 were "hot and blue (HB)", 10 were blue only and 38 were hot only. LN metastases rate was 16%: 9/90 SLNs (7 HB, 2 hot only) were positive for metastases in 6 patients. Four non-SLNs were found positive in 3 patients, and all presented concomitant positive SLNs. False negative rate was 0%. CONCLUSIONS: SPECT/CT had the highest detection rate and achieved the highest rate of bilateral mapping, compared to gamma-probe and MDB. SPECT/CT had moderate concordance with gamma-probe, and it can help the intraoperative detection of SLNs providing important information about their anatomic location.

Radio guided radical prostatectomy: evaluation of feasibility, safety and clinical outcomes.

BACKGROUND: The standard surgical treatment of PCa consists of radical prostatectomy (RP). Lymphadenectomy with removal of the sentinel lymph node (SLN) is now evolving towards the concept of radio guided surgery as an instrument for the removal of the lymph nodes of primary drainage. METHODS: From October 2012 to September 2013 laparotomic SLN dissection was performed in 43 patients during standard open radical prostatectomy. Twenty hours before surgery, 240 MBq of 99mTc nanocolloid were injected into the prostate gland under transrectal ultrasound guidance. A planar scintigraphy and a SPET/CT scan were performed 1-2 hours after the injection. Intraoperatively, all LNs detected by gamma-probe with an activity significantly higher than background were removed and classified as SLNs. We evaluated operative time, complications, postoperative outcomes and costs of the procedures of patients who underwent radio guided surgery. We measured radioactive exposure rates. RESULTS: The intraoperative detection of SLNs occurred in all 43 patients, while the scintigraphic localization was observed in 42/43 patients. A total of 77 SLNs were found, at histopathological analysis 7/77 SLNs resulted positive for metastases (4/43 patients): 3 were in the obturator fossa while the remaining SLNs were in the internal iliac chain (1), common iliac chain (1), external iliac chain (2). Global radiation exposure was not significant. CONCLUSION: Our preliminary data confirm the feasibility and the safety of SLN biopsy in nodal staging of PCa. The intraoperatively SLN detection rate resulted 100%. In 3 patients (7%) a micrometastases was found outside of obturator fossa in a not routinely sampled site.