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CompletedNCT02856347CMTpostopFDOPAUpdated Jun 26, 2026

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

An interventional study of 18F-DOPA in Medullary Thyroid Cancer, sponsored by Institut Claudius Regaud. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Medullary Thyroid Cancer

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Keywords

  • Medullary Thyroid Cancer
  • PET F-DOPA
  • 18-FDOPA
03

In context

Carcinoma, Medullary

65 studies on the registry are indexed under Carcinoma, Medullary; 17 are open to participants now.

This study's enrollment of 24 is below the median of 41 across 49 interventional studies indexed under Carcinoma, Medullary.

Browse Carcinoma, Medullary studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

Interventions

  • Other18F-DOPA

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

06

What researchers measure

Primary outcomes

  1. Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.

    Analysis will be performed by node.

    Time frame: up to 3 years

Secondary outcomes

  1. Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.

    Analysis will be performed by patient.

    Time frame: up to 3 years

  2. Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.

    Analyses will be performed by patient and by node.

    Time frame: up to 3 years

  3. Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.

    Analyses will be performed by patient and by metastasis.

    Time frame: up to 3 years

  4. Modification rate of patient's care after PET F-DOPA exam.

    Comparison of the modification of care (orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam.

    Time frame: up to 3 years

  5. The concordance between the PET F-DOPA results of each centre and centralized review.

    Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.

    Time frame: up to 3 years

07

Study locations

5 sites
  • CHU Haut-Lévêque
    Bordeaux, France
  • CHU Limoges
    Limoges, France
  • CHU Timone
    Marseille, France
  • ICM Montpellier
    Montpellier, France
  • Institut Claudius Regaud
    Toulouse, 31059, France
08

References and documents

Publications

  • Terroir M, Lusque A, Hindie E, Taieb D, Eberle-Pouzeratte MC, Verbeke S, Decote A, Grunenwald S, Zerdoud S. Prospective study on the [18F]FDOPA PET/CT role in the management of medullary thyroid cancer patients with high residual calcitonin level after surgery. Eur J Nucl Med Mol Imaging. 2026 Jun 24. doi: 10.1007/s00259-026-07992-2. Online ahead of print. PubMed 42337037 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02856347
Lead sponsor
Institut Claudius Regaud
Responsible party
Sponsor
First posted
Aug 4, 2016
Start date
Mar 22, 2017
Primary completion
Dec 20, 2020
Completion
Dec 20, 2020
Last update
Jun 26, 2026

Study contacts

Slimane Zerdoud, MD
principal investigator · Institut Claudius Regaud

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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