Medullary Thyroid CarcinomaTEPCMTNCT03636945
Evaluation of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma
A study testing PET at 18F-FDOPA in people with Medullary Thyroid Carcinoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- PET at 18F-FDOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2018to Sep 2021
- 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
- Major patient, affiliated to a social security scheme and having signed a written consent
- Patients with CMT (initial diagnosis)
- Serum calcitonin> 150 μg / ml
- Patient who had the baseline imaging assessment during the 3 months preceding the 18F-FDOPA PET scan (as recommended by the 2015 ATA (11)), according to the serum calcitonin level:
- 150 <Calcitonin <500: cervical ultrasound + cervico-thoracic CT scan
- Calcitonin ≥500: cervical ultrasound, cervico-thoracoabdominopelvic CT scan, bone MRI.
Who cannot join
- Pregnant women (positive pregnancy test) or lactating women can not be included.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
Official title: Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients.
Read more
The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.
Read the detailed description
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases (> 50% of cases) and sometimes visceral metastases (> 5%). Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases. Preliminary study, which included 9 CMT patients, 18F-FDOPA PET showed very promising results during the initial diagnosis, particularly in node staging.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients. The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations (as recommended by the 2015 ATA) within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.
Number of patients expected: 62. Duration of the study: 29 months of inclusion and 7 months of follow-up.
About 60 to 70 patients with a CMT are operated annually in the centers involved. Nuclear physicians, endocrine surgeons, endocrinologists and anatomopathologists work together in institutional and interinstitutional team meetings (SFE-RENATEN). Some of the centers have already collaborated on the implementation of a large PHRC-INCa project recently published in the JCEM.
- Conditions
- Medullary Thyroid Carcinoma
- Being tested
- PET at 18F-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.
PET at 18F-FDOPAOther
18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging
| Study group | Role | What they receive |
|---|---|---|
| Medullary thyroid carcinoma | Experimental | Patients with MTC who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol Receives: Other: PET at 18F-FDOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with aditionnal information
the proportion of CMT patients for whom 18F-FDOPA PET / CT PET provides additional information compared to the conventional imaging (CI) assessment at the initial diagnosis.
Measured: 90 MINUTES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636945
- Sponsor's protocol ID
- 2018-10
- Acronym
- TEPCMT
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03636945
- Acronym / sponsor ID
- TEPCMT / 2018-10
- Conditions
- Medullary Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Aug 2018 (actual)
- 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.
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients.
The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.
Detailed description
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases (> 50% of cases) and sometimes visceral metastases (> 5%). Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases. Preliminary study, which included 9 CMT patients, 18F-FDOPA PET showed very promising results during the initial diagnosis, particularly in node staging.
The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients. The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient.
This is a prospective, multicenter and open study.
Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations (as recommended by the 2015 ATA) within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.
Number of patients expected: 62. Duration of the study: 29 months of inclusion and 7 months of follow-up.
About 60 to 70 patients with a CMT are operated annually in the centers involved. Nuclear physicians, endocrine surgeons, endocrinologists and anatomopathologists work together in institutional and interinstitutional team meetings (SFE-RENATEN). Some of the centers have already collaborated on the implementation of a large PHRC-INCa project recently published in the JCEM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medullary thyroid carcinoma | Experimental | Other: PET at 18F-FDOPAPatients with MTC who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient, affiliated to a social security scheme and having signed a written consent
- Patients with CMT (initial diagnosis)
- Serum calcitonin> 150 μg / ml
- Patient who had the baseline imaging assessment during the 3 months preceding the 18F-FDOPA PET scan (as recommended by the 2015 ATA (11)), according to the serum calcitonin level:
Key exclusion criteria (1 listed)
- Pregnant women (positive pregnancy test) or lactating women can not be included.
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 |
|---|---|---|
| PET at 18F-FDOPA18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging | Other | Medullary thyroid carcinoma |
Primary outcome
number of patient with aditionnal information
Time frame: 90 MINUTES
the proportion of CMT patients for whom 18F-FDOPA PET / CT PET provides additional information compared to the conventional imaging (CI) assessment at the initial diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET at 18F-FDOPA in people with Medullary Thyroid Carcinoma, run by Assistance Publique Hopitaux De Marseille at 1 site 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact david TAIEB, MD (+33 491384706, David.TAIEB@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patient with aditionnal information (time frame: 90 MINUTES). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2018.