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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with lutathera | Experimental | Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Results of the dosimetry obtained from the 2 cameras | Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera. | 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40113220 | Result | Zaragori T, Chevalier E, Citerne Q, Roch V, Hossu G, Marie PY, Boursier C, Imbert L. Assessment of [177Lu]Lu-DOTATATE Dosimetry from High-Speed Whole-Body Recordings Provided by a 360 degrees Cadmium-Zinc-Telluride Camera Compared with Results from a Conventional Anger-Camera Protocol. J Nucl Med. 2025 May 1;66(5):771-777. doi: 10.2967/jnumed.124.268910. |
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| 24 hours, 96 hours, 168 hours |
| Correlation between the dosimetry results | 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). | 24 hours, 96 hours, 168 hours |