Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
Cuvinte cheie
Abstract
Descriere
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.
Datele
Ultima verificare: | 05/31/2020 |
Primul depus: | 06/21/2020 |
Inscriere estimată trimisă: | 07/07/2020 |
Prima postare: | 07/12/2020 |
Ultima actualizare trimisă: | 07/07/2020 |
Ultima actualizare postată: | 07/12/2020 |
Data actuală de începere a studiului: | 09/24/2020 |
Data estimată de finalizare primară: | 03/24/2022 |
Data estimată de finalizare a studiului: | 09/24/2022 |
Stare sau boală
Intervenție / tratament
Other: patients treated with lutathera
Fază
Grupuri de brațe
Braţ | Intervenție / tratament |
---|---|
Experimental: 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. | Other: patients treated with lutathera 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 |
Criterii de eligibilitate
Vârste eligibile pentru studiu | 18 Years La 18 Years |
Sexe eligibile pentru studiu | All |
Acceptă voluntari sănătoși | da |
Criterii | 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 |
Rezultat
Măsuri de rezultate primare
1. Results of the dosimetry obtained from the 2 cameras [168 hours]
Măsuri de rezultate secundare
1. 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]
2. Correlation between the dosimetry results [24 hours, 96 hours, 168 hours]