Dosimetry Using a CZT-camera Following LUTATHERA® Therapy

Dosimetry Clinical Trial

— EVADOVE177Lu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467567
• Other study ID #: 2020-A20200-620
• Status: Completed
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: July 24, 2023

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-CT™camera, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 24, 2023
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dosimetry

Intervention

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

Locations

Country	Name	City	State
France	Chru Nancy	Vandoeuvre/les/nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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