EVADOVE177Lu: Dosimetry Using a CZT-camera Following LUTATHERA® Therapy

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04467567
Collaborator
(none)
15
1
1
23.9
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Nov 27, 2020
Actual Primary Completion Date :
Mar 25, 2021
Anticipated Study Completion Date :
Nov 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Results of the dosimetry obtained from the 2 cameras [168 hours]

    Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.

Secondary Outcome Measures

  1. 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]

    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.

  2. Correlation between the dosimetry results [24 hours, 96 hours, 168 hours]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chru Nancy Vandoeuvre/les/nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04467567
Other Study ID Numbers:
  • 2020-A20200-620
First Posted:
Jul 13, 2020
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 5, 2021