Dosimetry Using a CZT-camera Following LUTATHERA® Therapy

NCT04467567 | Completed

• 1 other identifier: 2020-A20200-620
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dosimetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Correlation between the dosimetry results

  24 hours, 96 hours, 168 hours

Study Arms (1)

patients treated with lutathera

EXPERIMENTAL

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)

Interventions

Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) OTHER

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

patients treated with lutathera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major adult subject
• ECOG ≤ 2
• Subject receiving treatment with Lutathera®
• Subject having given written, free and informed consent
• Affiliation to a social security scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 13, 2020
• Study Start: November 27, 2020
• Primary Completion: March 25, 2021
• Study Completion: July 24, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)