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Trial record 59 of 231 for:    CALCITONIN SALMON

Evaluation of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma (TEPCMT)

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ClinicalTrials.gov Identifier: NCT03636945
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Medullary Thyroid Carcinoma Other: PET at 18F-FDOPA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: Medullary thyroid carcinoma
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
Other: PET at 18F-FDOPA
18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging




Primary Outcome Measures :
  1. 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.



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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:

  • 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.

Exclusion Criteria:

  • Pregnant women (positive pregnancy test) or lactating women can not be included.

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): NCT03636945


Contacts
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Contact: david TAIEB, MD +33 491384706 David.TAIEB@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille
Marseille, Paca, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE APHM

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03636945     History of Changes
Other Study ID Numbers: 2018-10
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs