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68-Gallium-DOTATATE-PET/CT Imaging for Thyroid Cancer
Phase 2
Recruiting
Led By Joanna Klubo-Gwiezdzinska, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with established thyroid cancer diagnosis presenting with locally advanced or distant metastases, which are RAI-non-avid based on the [123]I or [131]I diagnostic or post-treatment whole body scan (WBS)
Patients with MTC or suspected of locally advanced or metastatic MTC with calcitonin level > 500 pg/mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during baseline assessment
Awards & highlights
Study Summary
This trial is for people with thyroid cancer to see if 68Gallium-DOTATATE can help show where the cancer is.
Who is the study for?
This trial is for adults with thyroid cancer that has spread and doesn't respond to radioactive iodine treatment. Participants must have a confirmed diagnosis, show disease progression after RAI therapy, or have high calcitonin levels if they have medullary thyroid cancer.Check my eligibility
What is being tested?
Researchers are testing a new imaging method using 68Gallium-DOTATATE-PET/CT scans to detect tumors in patients whose thyroid cancer has become resistant to standard treatments. The study aims to improve tumor detection which could guide future therapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the IV injection of the tracer compound (like discomfort or bruising), exposure to radiation from PET/CT scans, and possible allergic reactions although specific side effects are not detailed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thyroid cancer has spread and does not respond to radioactive iodine treatment.
Select...
My calcitonin level is above 500 pg/mL, indicating advanced thyroid cancer.
Select...
My thyroid cancer is not responding to radioactive iodine and has worsened.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during baseline assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during baseline assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT
Secondary outcome measures
Correlation between tumor volume and SUV max for each participant
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE
Trial Design
3Treatment groups
Experimental Treatment
Group I: Medullary thyroid cancer (MTC)Experimental Treatment1 Intervention
Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)
Group II: Hurthle cell thyroid cancer (HTC)Experimental Treatment1 Intervention
Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),
Group III: Differentiated thyroid cancer (DTC)Experimental Treatment1 Intervention
Patients with DTC but not HTC
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,314,538 Total Patients Enrolled
Joanna Klubo-Gwiezdzinska, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
5 Previous Clinical Trials
5,626 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid cancer has spread and does not respond to radioactive iodine treatment.I have been diagnosed with thyroid cancer.I do not have serious conditions like kidney failure or heart failure.I am unable to understand and give consent for my treatment.My calcitonin level is above 500 pg/mL, indicating advanced thyroid cancer.My thyroid cancer is not responding to radioactive iodine and has worsened.
Research Study Groups:
This trial has the following groups:- Group 1: Differentiated thyroid cancer (DTC)
- Group 2: Hurthle cell thyroid cancer (HTC)
- Group 3: Medullary thyroid cancer (MTC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for more participants in this research project?
"This clinical trial is actively recruiting patients, as indicated on the website clinicaltrials.gov. The trial was first posted on October 25th, 2021 and was most recently updated on July 15th, 2022."
Answered by AI
What other research has been completed that uses 68-Gallium-DOTATATE-PET/CT?
"15 clinical trials for 68-Gallium-DOTATATE-PET/CT are currently underway with 0 in Phase 3. Of the 47 locations across the United States conducting these trials, many of them are based in Bethesda, Maryland."
Answered by AI
Does 68-Gallium-DOTATATE-PET/CT put patients at high risk?
"68-Gallium-DOTATATE-PET/CT was given a Phase 2 score, meaning that while there is some data suggesting it is safe, none of the trials have shown it to be effective."
Answered by AI
What is the total number of people participating in this research project?
"The available information does support that this trial is actively recruiting patients. According to the clinicaltrials.gov website, the trial was posted on October 25th 2021 and edited most recently on July 15th 2022. They are looking for 54 individuals total from 1 site."
Answered by AI
Has this research been conducted before?
"As of now, there are 15 trials being conducted for 68-Gallium-DOTATATE-PET/CT in 19 different cities spanning 13 countries. The earliest study was completed in 2016 by Ozmosis Research Inc. and involved 195 people. In the 4 years since then, 2 more studies have been completed."
Answered by AI
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