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Thyroid Cancer and (FDG)PET/CT Scan

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ClinicalTrials.gov Identifier: NCT04128631
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
RMFarghali, Assiut University

Brief Summary:

Background and Rational

(Introduction)

Differentiated thyroid carcinoma (DTC) have favorable prognosis. Overall 10-year survival is 93% for papillary carcinoma, and 85% for follicular carcinoma(1). After total thyroidectomy followed by radioiodine remnant ablation, DTC patients are screened for recurrence by measuring the levels of both Tg and TgAb and I-131 whole body scan (WBS) in the follow-up (2) It is reported that elevated TgAb may indicate the recurrent and/or metastatic disease and can be used as an alternative of the tumor marker for DTC . The I-131 WBS has high specificity to detect recurrence (50 to 60% in papillary thyroid carcinoma and 64 to 67% in follicular thyroid carcinoma) (3,4). The I-131WBS showed negative finding in 10 to 15% of patients with detectable serum Tg levels(5). Two factors may account for discrepancy between serum Tg and I-131 WBS . First, the tumor size might be too small to be detected by WBS. Second, the tumor cell may lose the ability to trap radioiodine while still able to secret Tg(6,7). It becomes necessary to investigate with other modalities to identify possible residual disease to initiate the appropriate treatment. (8)

Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) has emerged as a powerful imaging tool for the detection of various cancers. (9)

The combined acquisition of PET and CT has synergistic advantages over PET or CT alone and minimizes their individual limitations. (10)

It is a valuable tool for staging and re staging of some tumors and has an important role in the detection of recurrence in asymptomatic patients with rising tumor marker levels and patients with negative or equivocal findings on conventional imaging techniques.(11)

Aim of the study

The aim of this study was to evaluate the diagnostic accuracy of (PET/CT) in patients with suspected thyroid cancer recurrence or metastasis , with differentiated thyroid cancer (DTC) patients who show elevated serum thyroglobulin (Tg) or antithyroglobulin antibody (TgAb) level with negative radioiodine whole body scan (I-WBS).


Condition or disease
Thyroid Cancer

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 35 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Role of of F-18-fluoro-deoxy-glucose (FDG) PET/CT in Thyroid Cancer Patients With Negative I-131whole Body Scan and Elevated Thyroglobulin Level or Positive Anti Thyroglobulin Antibodies
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
PET/CT
group of patients will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels.



Primary Outcome Measures :
  1. Recurrence and metastasis [ Time Frame: six months ]
    Detection of recurrence or metastasis in patient with negative radioactive iodine scan and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.By progressively increase level of serum Thyroglobulin or thyroglobulin antibodies


Secondary Outcome Measures :
  1. Improve survival rate [ Time Frame: six months ]
    initiate appropriate treatment to those patients improve survival and quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
Criteria

Inclusion Criteria:

  • · This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.

    • Patients able to sleep in a fixed position for 20 minutes.

Exclusion Criteria:

Patients unable to sit calm without movement during imaging.

  • Severely ill patients.
  • Patients' blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
  • Pregnancy

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Responsible Party: RMFarghali, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04128631     History of Changes
Other Study ID Numbers: FDGPET
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: September 2019

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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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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs