Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)

March 5, 2021 updated by: Institut Claudius Regaud

Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET ( Positron Emission Tomography) F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin

The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.

This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.

The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.

Obtained data will be compared to the "gold standard" based on :

  • nodes cytology when they could be punctured
  • histology when a new surgery will be recommended
  • surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Haut-Leveque
      • Limoges, France
        • CHU Limoges
      • Marseille, France
        • CHU Timone
      • Montpellier, France
        • Icm Montpellier
      • Toulouse, France, 31059
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > or = 18 years.
  2. Patient with medullary thyroid cancer (sporadic or hereditary form).
  3. Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
  4. Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
  5. Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
  6. Standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic CT-scan and/or a cervico-thoraco-abdomino-pelvic CT-scan and a liver MRI.
  7. Patient able to be followed at least 6 months after PET 18-FDOPA.
  8. If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
  9. Patient must provide written informed consent prior to any specific procedure or assessment.
  10. Patient must be affiliated to the French Social Security System.

Exclusion Criteria:

  1. Pregnant patient.
  2. Post-operative radiotherapy initiated before PET 18-FDOPA.
  3. Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
  4. Participation in any other clinical trial for therapeutic use.
  5. Patient with PET / CT-scan exam contra-indication.
  6. Any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures.
  7. Patient protected by law.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PET 18-FDOPA

18F-DOPA will be administered with an activity of 1.5-4 MBq/kg (MegaBecquerel) in the IV (Intra venous) tubing to decrease the extravasation risk and tracer lymphatic migration. The injection site will be distant from pathologic area (forearm).

PET CT exam will start 10 min after tracer injection and will cover the whole body (10 to 30 min).

Other series of images will be done 50 min after tracer injection. Images will be interpreted.
Other: 18F-DOPA
Injection of 18F-DOPA and PET / CT-scan assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Time Frame: up to 3 years
Analysis will be performed by node.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Time Frame: up to 3 years
Analysis will be performed by patient.
up to 3 years
Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.
Time Frame: up to 3 years
Analyses will be performed by patient and by node.
up to 3 years
Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.
Time Frame: up to 3 years
Analyses will be performed by patient and by metastasis.
up to 3 years
Modification rate of patient's care after PET F-DOPA exam.
Time Frame: up to 3 years
Comparison of the modification of care (orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam.
up to 3 years
The concordance between the PET F-DOPA results of each centre and centralized review.
Time Frame: up to 3 years
Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Slimane Zerdoud, MD, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16VADS03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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