search
Back to results

Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer (DOPMET)

Primary Purpose

Thyroid Neoplasm, Thyroid Carcinoma, Medullary Carcinoma

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
18F-L-DOPA PET
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Neoplasm focused on measuring Thyroid neoplasm, Thyroid carcinoma, Medullary carcinoma, Positron Emission Tomography (PET), 18F-L DOPA, Calcitonin, Carcinoembryonic Antibodies, Cervical ultrasonography, Cervical-chest-abdomen tomography, Cervical-chest-abdomen magnetic resonance imaging, Osseous radionuclide imaging, Post-PET surgery, Post-PET biopsy, Post-PET histology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients up to 18 years old with medullary thyroid cancer / carcinoma
  • Patients with medullary thyroid cancer / carcinoma recurrence, which have a high calcitonin level / rate, more than 100pg/ml, associated - or not - to a high CEA (Carcinoembryonic Antibodies) level / rate, dated from less than 3 months
  • Patients with a less than 3 months conventional imaging checkup (cervical ultrasonography, cervical-chest-abdomen tomography and / or magnetic resonance imaging, abdomen ultrasonography, osseous / bones radionuclide imaging), in which the tumor site not certainty located
  • Informed Consent Form signed and dated by patients
  • Patients which are "SECURITE SOCIALE" affiliated

Exclusion criteria:

  • Pregnant or suckling women
  • Women able to procreate, without efficient birth control
  • Patients already included in another Nuclear Medicine or Imaging research protocol using ionizing radiations; the efficient dose accumulation will not exceed 20 mSv.

Sites / Locations

  • Hôpital Antoine Beclere

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

18F-L6DOPA PET

Outcomes

Primary Outcome Measures

Any tracer accumulation exceeding the normal uptake tissue searched by two experienced nuclear medicine physicians and compared by malignant tissue confirmed by histology after biopsy, surgery or by follow-up for one year.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2008
Last Updated
July 6, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT00647140
Brief Title
Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer
Acronym
DOPMET
Official Title
Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
Insuffisent recruitment
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.
Detailed Description
In patients MTC and persistently elevated calcitonin levels, the challenge is finding the site of residual disease. Since the only satisfying treatment is surgery, the early detection and precise location is important. Tumor localization techniques usually performed, including ultrasonography of the neck and liver, chest and abdomen, bone scintigraphy, isotopic scanning and even PET with FDG are poorly sensitive. The use of 18F-DOPA may be more sensitive and specific engineering for localization metastatic disease. The study include 100 patient with persistent MTC demonstrated by elevated tumor markers (calcitonin and CEA) and no evidence of recurrence on morphological imaging procedures. 18F-DOPA whole-body PET is performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA, the patient fasted for 6 hours prior the start of the examination. All 18F-DOPA PET are evaluated independently by two experienced nuclear medicine physicians and any tracer accumulation exceeding the normal uptake tissue is rated as pathologic finding. The sensibility and efficiency of 18F-DOPA PET will be analysed and Malignant tissue confirmed by histology after surgery or biopsy or by follow-up for one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm, Thyroid Carcinoma, Medullary Carcinoma
Keywords
Thyroid neoplasm, Thyroid carcinoma, Medullary carcinoma, Positron Emission Tomography (PET), 18F-L DOPA, Calcitonin, Carcinoembryonic Antibodies, Cervical ultrasonography, Cervical-chest-abdomen tomography, Cervical-chest-abdomen magnetic resonance imaging, Osseous radionuclide imaging, Post-PET surgery, Post-PET biopsy, Post-PET histology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
18F-L6DOPA PET
Intervention Type
Other
Intervention Name(s)
18F-L-DOPA PET
Other Intervention Name(s)
18F-L-DOPA Positron Emission Tomography
Intervention Description
PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA
Primary Outcome Measure Information:
Title
Any tracer accumulation exceeding the normal uptake tissue searched by two experienced nuclear medicine physicians and compared by malignant tissue confirmed by histology after biopsy, surgery or by follow-up for one year.
Time Frame
At the 18F-L-DOPA PET and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients up to 18 years old with medullary thyroid cancer / carcinoma Patients with medullary thyroid cancer / carcinoma recurrence, which have a high calcitonin level / rate, more than 100pg/ml, associated - or not - to a high CEA (Carcinoembryonic Antibodies) level / rate, dated from less than 3 months Patients with a less than 3 months conventional imaging checkup (cervical ultrasonography, cervical-chest-abdomen tomography and / or magnetic resonance imaging, abdomen ultrasonography, osseous / bones radionuclide imaging), in which the tumor site not certainty located Informed Consent Form signed and dated by patients Patients which are "SECURITE SOCIALE" affiliated Exclusion criteria: Pregnant or suckling women Women able to procreate, without efficient birth control Patients already included in another Nuclear Medicine or Imaging research protocol using ionizing radiations; the efficient dose accumulation will not exceed 20 mSv.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badia-Ourkia HELAL, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer

We'll reach out to this number within 24 hrs