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


Phase 2
18 Years
N/A
Not Enrolling
Both
Thyroid Neoplasm, Thyroid Carcinoma, Medullary Carcinoma

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

At the 18F-L-DOPA PET and 1 year

Safety Issue:

No

Principal Investigator

Badia-Ourkia HELAL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Authority:

France: Ministry of Health

Study ID:

P051081

NCT ID:

NCT00647140

Start Date:

August 2007

Completion Date:

February 2010

Related Keywords:

  • Thyroid Neoplasm
  • Thyroid Carcinoma
  • Medullary Carcinoma
  • 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
  • Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Carcinoma, Medullary

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