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Trial record 4 of 116 for:    medullary carcinoma

Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (CMTpostopFDOPA)

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ClinicalTrials.gov Identifier: NCT02856347
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE March 22, 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
relative rate of TRUE positive with PET -FDOPA compared to standard imaging assessment (analyse by patient) [ Time Frame: up to 3 years ]
a standard CT will be performed before inclusion and a PET FDOPA will be performed the day after inclusion
Change History Complete list of historical versions of study NCT02856347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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 patient.
  • Relative rate of FALSE positive nodes with PET F-DOPA compared to standard imaging assessment. [ Time Frame: up to 3 years ]
    Analyses will be performed by patient and by node.
  • Relative rate of TRUE positive and FALSE metastasis with PET F-DOPA compared to standard imaging assessment. [ Time Frame: up to 3 years ]
    Analyses will be performed by patient and by metastasis.
  • Modification rate of patient's care after PET F-DOPA exam. [ Time Frame: up to 3 years ]
    Comparison of the modification of care (orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam.
  • The concordance between the PET F-DOPA results of each centre and centralized review. [ Time Frame: up to 3 years ]
    Concordance (centre / reviewer) of PET F-DOPA result interpretation will be evaluated.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • relative rate of FALSE positive with PET -FDOPA compared to standard imaging assessment (analyse by lesion) [ Time Frame: up to 3 years ]
    analyse by lesion and by patient : a standard CT will be performed before inclusion and a PET FDOPA will be performed after inclusion
  • Modification rate of patient's care after PET-FDOPA exam [ Time Frame: up to 3 years ]
    comparison of the modification of care ( orientation to a surgery or a surveillance) decided after standard imaging assessment following result of TEP-FDOPA exam
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
Official Title  ICMJE 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
Brief 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 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Medullary Thyroid Cancer
Intervention  ICMJE Other: 18F-DOPA
Injection of 18F-DOPA and PET / CT-scan assessment
Study Arms  ICMJE PET 18-FDOPA

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.

Intervention: Other: 18F-DOPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > or = 18 years.
  2. Patient with medullary thyroid cancer (sporadic or hereditary form).
  3. Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
  4. Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
  5. Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
  6. 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.
  7. Patient able to be followed at least 6 months after PET 18-FDOPA.
  8. If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
  9. Patient must provide written informed consent prior to any specific procedure or assessment.
  10. Patient must be affiliated to the French Social Security System.

Exclusion Criteria:

  1. Pregnant patient.
  2. Post-operative radiotherapy initiated before PET 18-FDOPA.
  3. Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
  4. Participation in any other clinical trial for therapeutic use.
  5. Patient with PET / CT-scan exam contra-indication.
  6. 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.
  7. Patient protected by law.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Slimane Zerdoud, MD 0033 05 31 15 56 28 zerdoud.slimane@iuct-oncopole.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02856347
Other Study ID Numbers  ICMJE 16VADS03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Slimane Zerdoud, MD Institut Claudius Regaud
PRS Account Institut Claudius Regaud
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP