Clinical trial NCT04467567: Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dosimetry
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Major adult subject
* ECOG ≤ 2
* 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

Primary outcomes:
measure: Results of the dosimetry obtained from the 2 cameras
timeFrame: 168 hours
Secondary outcomes:
measure: Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement
timeFrame: 24 hours, 96 hours, 168 hours
measure: Correlation between the dosimetry results
timeFrame: 24 hours, 96 hours, 168 hours
Other outcomes:
Locations:
city: Vandoeuvre/les/nancy
country: France
facility: Chru Nancy
Study officials:
References: