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Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer Patients

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ClinicalTrials.gov Identifier: NCT03065218
Recruitment Status : Suspended (PI's clinical privileges at MedStar Washington Hospital Center have expired)
First Posted : February 27, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Van Nostrand, Washington Hospital Center

Brief Summary:

This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who have elevated serum thyroglobulin levels and negative diagnostic imaging tests.

This is for patients with:

  • Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
  • All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
  • If EDCIS (extensive diagnostic clinical imaging studies of 18F-sodium fluoride positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), AND negative brain CT or magnetic resonance (MR) are performed, these are also negative.

Voluntary patients will have sestamibi scan performed in 4 phases:

Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.

Phase 2: wait for 60 to 90 minutes in a waiting room

Phase 3: imaged lying face up on an imaging table while a camera passes around you from the top of the head to approximately the level of knees. This requires approximately 45 minutes

Phase 4: images will be reviewed by the nuclear medicine physician. This will take ~10-15 minutes. If additional images are required to clarify an image, then additional images of that area will be performed on the same camera or an alternate camera. As earlier, the additional images performed lying face up. These images require ~20-45 minutes. The patient will then be released.

The risk of this study is considered very low, and the potential benefits to the patient are considered very high.


Condition or disease Intervention/treatment Phase
Thyroid Cancer Radiation: 99mTc sestamibi Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Actual Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 99mTc sestamilbi
25 mCi 99mTc sestamibi intravenous injection, once. Then imaged for 45 minutes. More imaging might be required and this will be determined by a nuclear medicine physician onsite
Radiation: 99mTc sestamibi
The patient will receive an injection into the vein of a radioisotope 99mTc sestamibi dose 25mCi and will be imaged in 1 day.




Primary Outcome Measures :
  1. Lesion detection on 99mTc Sestamibi Study [ Time Frame: 1 year ]
    Any area of radioactivity will be graded by a team of two blinded nuclear medicine physicians to determine if the uptake focus is metastatic disease.



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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:

  • > 18 years of age;
  • Diagnosed with differentiated thyroid carcinoma;
  • At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment, and treatment of distant metastases,
  • Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
  • All NEGATIVE standard diagnostic clinical imaging studies (SDCIS) = negative ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
  • If extensive diagnostic clinical imaging studies (EDCIS) of 18F-sodium fluoride positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), AND brain CT or magnetic resonance (MR) are performed, these are also negative.

Exclusion Criteria:

  • < 18 years of age;
  • Pregnant or breast feeding
  • Any SDCIS or EDCIS that is positive and/or suggestive of recurrent and/or distant metastases secondary to DTC. If a study is indeterminate, this will be forwarded to a committee for review and resolution.

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): NCT03065218


Locations
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United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Washington Hospital Center
Investigators
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Principal Investigator: Douglas Van Nostrand, MD Medstar Health Research Institute

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Responsible Party: Douglas Van Nostrand, Director, Nuclear Medicine Research, Washington Hospital Center
ClinicalTrials.gov Identifier: NCT03065218     History of Changes
Other Study ID Numbers: 2016-166
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Douglas Van Nostrand, Washington Hospital Center:
Thyroid
sestamibi

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action