Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
- Conditions
- Dosimetry
- Interventions
- Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
- Registration Number
- NCT04467567
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Major adult subject
- ECOG ≤ 2
- Subject receiving treatment with Lutathera®
- Subject having given written, free and informed consent
- Affiliation to a social security scheme
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients treated with lutathera Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.
- Primary Outcome Measures
Name Time Method Results of the dosimetry obtained from the 2 cameras 168 hours Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.
- Secondary Outcome Measures
Name Time Method 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 Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.
Correlation between the dosimetry results 24 hours, 96 hours, 168 hours Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate \[GFR\], blood ionogram), and versus bone marrow activity (blood count).
Trial Locations
- Locations (1)
Chru Nancy
🇫🇷Vandoeuvre/les/nancy, France