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

Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate

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.

Study Overview

• Status: Completed
• Conditions: Dosimetry
• Intervention / Treatment: Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre/les/nancy, France, 54511
    • Chru Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A20200-620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No