99mTc Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer (DTC) Patients

NCT03065218 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016-166
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

Thyroid; sestamibi

Outcome Measures

Primary Outcomes (1)

• Lesion Detection on 99mTc Sestamibi Study

  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.

  1 year

Study Arms (1)

99mTc sestamilbi

EXPERIMENTAL

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

Drug: 99mTc sestamibi

Interventions

99mTc sestamibi DRUG

The administration of the diagnostic radioisotope, 99mTc sestambi, to image possible metastases in patients with differentiated thyroid cancer.

99mTc sestamilbi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Diagnosed with differentiated thyroid carcinoma;
• At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment, and/or 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Diseases

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Results Point of Contact

• Title: Dr. Douglas Van Nostrand
• Organization: MedStar Health Research Institute

douglasvannostrand@gmail.com

202-877-0300

Study Officials

• Douglas Van Nostrand, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical evaluation of utility of the FDA approved radiopharmaceutical (i.e., 99mTc sestamibi) for differentiated thyroid cancer in a select patient populaton of patients with elevated serum thyroglobulin levels and negative diagnostic radioiodine scans with the objective of determining utility in identifying the site of metastasis(es) that is accounting for the elevated serum thyroglobulin level.

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: February 27, 2017
• Study Start: October 1, 2016
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)