Dosimetry Using a CZT-camera Following LUTATHERA® Therapy (EVADOVE177Lu)

Central Hospital, Nancy, France

Status: Completed

Conditions: Dosimetry

Treatments: Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04467567

2020-A20200-620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

patients treated with lutathera

Experimental group

Description:

Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.

Treatment:

Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)