Dosimetry Using a CZT-camera Following LUTATHERA Therapy

  • STATUS
    Recruiting
  • End date
    Nov 25, 2022
  • participants needed
    15
  • sponsor
    Central Hospital, Nancy, France
Updated on 13 August 2021

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-CTcamera, respectively.

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.

Details
Condition Radiation Dosimetry
Treatment Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
Clinical Study IdentifierNCT04467567
SponsorCentral Hospital, Nancy, France
Last Modified on13 August 2021

Eligibility

Yes No Not Sure

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
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