Using 68-Gallium-DOTATATE-PET/CT to improve imaging of metastatic thyroid cancer
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
This study is testing a new imaging method using a special substance called 68-Gallium-DOTATATE to see if it can better detect metastatic thyroid cancer that doesn't respond to regular treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 98 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04927416 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the detection of metastatic thyroid cancer that is resistant to standard radioactive iodine treatment by utilizing 68Gallium-DOTATATE in PET/CT imaging. Participants, aged 18 and older, will undergo a medical examination, provide blood and urine samples, and receive both the experimental imaging and standard care scans within a three-month period. The research focuses on patients with high expression of somatostatin receptors in their tumors, comparing different subtypes of thyroid cancer to better understand their imaging characteristics and molecular signatures.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic thyroid cancer that is non-responsive to radioactive iodine treatment.
Not a fit: Patients with thyroid cancer that is responsive to standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved detection and treatment options for patients with difficult-to-treat metastatic thyroid cancer.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other cancer types, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Data prospectively collected from the 28 subjects enrolled under this protocol, and data from 26 subjects collected under 77-DK-0096 and/or 00-CH-0093 will be analyzed. Among the 26 subjects prospectively evaluated under 77-DK-0096 protocol, 21 out of 26 had research 68Ga-DOTATATE PET/CT performed under the DOTATATE sub-study of 77-DK-0096, and 5 out of 26 had 68Ga-DOTATATE PET/CT done under 00-CH-0093. Again, the inclusion of the above data was per the IRB s request to transition the sub-study into a new standalone protocol. This will give us a total of 54 subjects for the final analyses, with at least 18 subjects from each group (e.g., HTC, DTC, and MTC), which is required to meet the primary objectives of this study with sufficient power of 80% and type 1 error alpha of \< 0.05. Patients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Ga-DOTATATE PET/CT imaging informed consent form. The same inclusion/exclusion criteria were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093. In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with established thyroid cancer diagnosis presenting with either: * Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS) OR --Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI. In order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level \> 500 pg/mL. EXCLUSION CRITERIA: Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study: * Pregnancy or lactation by self-report. * Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma; * Patients unable to give informed consent.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Joanna Klubo-Gwiezdzinska, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Padmasree Veeraraghavan, R.N.
- Email: padmasree.veeraraghavan@nih.gov
- Phone: (301) 451-7710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.