Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Results of the dosimetry obtained from the 2 cameras
Study Overview
Brief Summary
The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.
Detailed Description
177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with [177Lu]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major adult subject
- •Subject receiving treatment with Lutathera®
- •Subject having given written, free and informed consent
- •Affiliation to a social security scheme
Exclusion Criteria
- •Contraindication to treatment with Lutathera®
- •Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- •Pregnant woman, parturient or nursing mother.
- •Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
- •Subject unable to express consent.
- •Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L.3213-1
Arms & Interventions
patients treated with lutathera
Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.
Intervention: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) (Other)
Outcomes
Primary Outcomes
Results of the dosimetry obtained from the 2 cameras
Time Frame: 168 hours
Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.
Secondary Outcomes
- Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement(24 hours, 96 hours, 168 hours)
- Correlation between the dosimetry results(24 hours, 96 hours, 168 hours)
Investigators
Elodie CHEVALIER
Principal investigator
Central Hospital, Nancy, France