Current partner codePEPTIDESDE
NCT02856347·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

24

Locations

5

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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)

Interventions

Treatment arms and agents.

OTHER

18F-DOPA

Injection of 18F-DOPA and PET / CT-scan assessment

Timeline

From registration to results.

  1. First posted

    Aug 4, 2016

  2. Study start

    Mar 22, 2017

  3. Primary completion

    Dec 20, 2020

  4. Study completion

    Dec 20, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jun 26, 2026

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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.

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.

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.

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.

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

5 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

CHU Haut-Lévêque

Bordeaux, France

CHU Limoges

Limoges, France

CHU Timone

Marseille, France

ICM Montpellier

Montpellier, France

Institut Claudius Regaud

Toulouse, France

Related trials

More studies on Calcitonin.

Related PeptideStat pages

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