Dosimetry
Conditions
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.
Interventions
SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed