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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)

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ClinicalTrials.gov Identifier: NCT02856347
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Study Description
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Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Medullary Thyroid Cancer Other: 18F-DOPA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : December 20, 2020
Actual Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856347


Locations
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France
CHU Haut-Lévêque
Bordeaux, France
CHU Limoges
Limoges, France
CHU Timone
Marseille, France
ICM Montpellier
Montpellier, France
Institut Claudius Regaud
Toulouse, France, 31059
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Principal Investigator: Slimane Zerdoud, MD Institut Claudius Regaud
More Information
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT02856347    
Other Study ID Numbers: 16VADS03
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Medullary Thyroid Cancer
PET F-DOPA
18-FDOPA
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue