Medullary Thyroid CancerCMTpostopFDOPANCT02856347
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
A study testing 18F-DOPA in people with Medullary Thyroid Cancer, run by Institut Claudius Regaud at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- 18F-DOPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesFrance
- Study dates
- 22 Mar 2017to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years.
- Patient with medullary thyroid cancer (sporadic or hereditary form).
- Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
- Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
- Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
- 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.
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- Patient able to be followed at least 6 months after PET 18-FDOPA.
- If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
- Patient must provide written informed consent prior to any specific procedure or assessment.
- Patient must be affiliated to the French Social Security System.
Who cannot join
- Pregnant patient.
- Post-operative radiotherapy initiated before PET 18-FDOPA.
- Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
- Participation in any other clinical trial for therapeutic use.
- Patient with PET / CT-scan exam contra-indication.
- 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.
- Patient protected by law.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Haut-Lévêque
Bordeaux
CHU Limoges
Limoges
CHU Timone
Marseille
ICM Montpellier
Montpellier
Institut Claudius Regaud
Toulouse, 31059
About this study
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
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.
Read more
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)
- Conditions
- Medullary Thyroid Cancer
- Being tested
- 18F-DOPA
- Keywords
- Medullary Thyroid Cancer, PET F-DOPA, 18-FDOPA
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DOPAOther
Injection of 18F-DOPA and PET / CT-scan assessment
| Study group | Role | What they receive |
|---|---|---|
| PET 18-FDOPA | Other | 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. Receives: Other: 18F-DOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Analysis will be performed by node.
Measured: up to 3 years
Secondary outcomes (5)
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Analysis will be performed by patient.
Measured: up to 3 years
Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment.
Analyses will be performed by patient and by node.
Measured: up to 3 years
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.
Measured: up to 3 years
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.
Measured: up to 3 years
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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start22 Mar 2017
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slimane Zerdoud, MD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856347
- Sponsor's protocol ID
- 16VADS03
- Acronym
- CMTpostopFDOPA
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2016
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02856347
- Acronym / sponsor ID
- CMTpostopFDOPA / 16VADS03
- Conditions
- Medullary Thyroid Cancer
- Keywords
- Medullary Thyroid Cancer, PET F-DOPA, 18-FDOPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET 18-FDOPA | Other | Other: 18F-DOPA18F-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > or = 18 years.
- Patient with medullary thyroid cancer (sporadic or hereditary form).
- Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
- Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
- Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
Key exclusion criteria (7 listed)
- Pregnant patient.
- Post-operative radiotherapy initiated before PET 18-FDOPA.
- Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
- Participation in any other clinical trial for therapeutic use.
- Patient with PET / CT-scan exam contra-indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DOPAInjection of 18F-DOPA and PET / CT-scan assessment | Other | PET 18-FDOPA |
Primary outcome
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.
5 secondary outcomes
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment.
Time frame: 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
Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment.
Time frame: up to 3 years
Modification rate of patient's care after PET F-DOPA exam.
Time frame: up to 3 years
The concordance between the PET F-DOPA results of each centre and centralized review.
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Results publication: PubMed 42337037Terroir 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slimane Zerdoud, MD principal investigator
Institut Claudius Regaud
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DOPA in people with Medullary Thyroid Cancer, run by Institut Claudius Regaud at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative rate of TRUE positive nodes with PET F-DOPA compared to standard imaging assessment. (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02856347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.