68-Gallium-DOTATATE-PET/CT Imaging for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Joanna Klubo-Gwiezdzinska, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Disqualifiers: Pregnancy, Renal failure, Cardiac failure, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment options are limited and generally not effective. Researchers want to see if they can better detect thyroid tumors by using a compound called 68Gallium-DOTATATE. This compound may bind to a tumor and make it visible during a positron emission tomography/computed tomography (PET/CT) scan. This information might help guide future research and treatment. Objective: To identify the people with thyroid cancer whose tumors have a high uptake of 68Gallium-DOTATATE as analyzed by imaging with PET/CT. Eligibility: People ages 18 years and older with thyroid cancer that has spread outside of the thyroid. Design: Participants will have a medical exam. They will give blood and urine samples. Some samples will be used for research. Participants will have imaging scans that follow standard of care. These scans may include: CT scan of the neck, chest, abdomen, and pelvis Bone scan Magnetic resonance imaging of the brain, spine, or liver 18-FDG-PET/CT as needed Participants will have a PET/CT scan. They will get an intravenous (IV) line. They will get an IV injection of 68Gallium-DOTATATE. It contains radioactive tracers. The PET/CT scanner is shaped like a large donut. It contains crystals. The crystals pick up small radiation signals that are given off by the tracers. The CT part of the scan uses low-dose x-rays. The pictures made by the scanner show where the tracers are in the body. The session will last 90 minutes. Participation will last for about 3 months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment 68-Gallium-DOTATATE-PET/CT for thyroid cancer?

Research shows that 68-Gallium-DOTATATE-PET/CT can detect thyroid tumors because they often have somatostatin receptors, which this imaging targets. It has been useful in identifying thyroid cancer in patients with other types of tumors, suggesting it could help in detecting thyroid cancer. ^{1 2 3 4 5}

Is 68-Gallium-DOTATATE-PET/CT imaging safe for humans?

68-Gallium-DOTATATE-PET/CT has been used safely in humans for imaging neuroendocrine tumors, and it is approved by the FDA for this purpose. While specific safety data for thyroid cancer is not detailed, its use in other conditions suggests it is generally safe for human use. ^{1 4 6 7 8}

How does 68-Gallium-DOTATATE-PET/CT imaging differ from other treatments for thyroid cancer?

68-Gallium-DOTATATE-PET/CT imaging is unique because it uses a radiolabeled peptide to target somatostatin receptors, which are often present in thyroid tumors. This imaging method provides higher sensitivity and better spatial resolution compared to traditional imaging techniques, making it particularly useful for detecting and evaluating thyroid cancer. ^{1 9 10 11 12}

Research Team

Joanna Klubo-Gwiezdzinska, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

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.

Inclusion Criteria

My thyroid cancer has spread and does not respond to radioactive iodine treatment.

I have been diagnosed with thyroid cancer.

My calcitonin level is above 500 pg/mL, indicating advanced thyroid cancer.

Exclusion Criteria

I do not have serious conditions like kidney failure or heart failure.

I am unable to understand and give consent for my treatment.

Pregnancy or lactation by self-report

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline imaging and assessments, including PET/CT scans and other standard of care imaging

1-2 weeks

1 visit (in-person)

Experimental Imaging

Participants receive a one-time experimental 68Ga-DOTATATE PET/CT scan to assess tumor characteristics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 68-Gallium-DOTATATE-PET/CT (Radiopharmaceutical)

Trial Overview 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.

Participant Groups

Group I: Medullary thyroid cancer (MTC) Experimental Treatment 1 Intervention

Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)

Group II: Hurthle cell thyroid cancer (HTC) Experimental Treatment 1 Intervention

Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),

Group III: Differentiated thyroid cancer (DTC) Experimental Treatment 1 Intervention

Patients with DTC but not HTC

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

In a study of 237 patients undergoing Ga-68 DOTATATE PET/CT for neuroendocrine tumors, 11% exhibited atypical thyroid uptake, indicating a notable occurrence that warrants further investigation.

Among patients with focal uptake, 71% had thyroid nodules, and 21% were diagnosed with papillary thyroid cancer, highlighting the importance of clinical evaluation for potential malignancies in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. Nockel, P., Millo, C., Keutgen, X., et al.[2019]

68Ga-DOTATOC PET/CT is effective in detecting recurrence or metastases in differentiated thyroid carcinoma (DTC) patients who have elevated thyroglobulin levels but negative results from both radioiodine imaging and 18F-FDG PET/CT, with true-positive results in 5 out of 15 patients.

The imaging technique showed particularly high efficacy in poorly differentiated and oxyphilic subtypes of DTC, suggesting it could be a valuable tool for identifying tumors that other imaging methods might miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATOC PET/CT in Patients with Iodine- and 18F-FDG-Negative Differentiated Thyroid Carcinoma and Elevated Serum Thyroglobulin. Binse, I., Poeppel, TD., Ruhlmann, M., et al.[2017]

In a study of 81 patients with neuroendocrine tumors (NETs), Ga-68 DOTATATE PET/CT was more effective than F-18 FDG PET/CT in detecting positive scans in patients with low and intermediate-grade tumors, with 82.1% of DOTATATE scans positive compared to 54.5% for FDG (P = 0.04).

For high-grade, poorly-differentiated NETs, both DOTATATE and FDG PET/CT scans were equally effective, with all patients showing positive results, indicating that while DOTATATE is superior for lower-grade tumors, it does not provide additional benefits for high-grade tumors compared to FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. You, H., Kandathil, A., Beg, M., et al.[2021]

Ga-DOTATATE is an FDA-approved imaging agent for neuroendocrine tumors (NETs) and is being explored for its effectiveness in detecting medullary thyroid cancer, especially when somatostatin analogs are considered for treatment.

In a case study of a 55-year-old man, Ga-DOTATATE PET/CT successfully identified both well-differentiated NET liver metastases and an incidental medullary thyroid carcinoma, highlighting its potential utility in diagnosing multiple malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental Detection of Medullary Thyroid Carcinoma by 68Ga-DOTATATE PET/CT in a Patient With Neuroendocrine Tumor Liver Metastases. Mahajan, S., Shaha, A., Grewal, RK.[2019]

The case study highlights a 55-year-old man with aggressive, poorly differentiated metastatic thyroid cancer that did not respond to radioactive iodine, indicating the need for alternative imaging and treatment strategies.

Using 68Ga-DOTATATE and 68Ga-PSMA PET/CT revealed different patterns of tumor uptake, showcasing the heterogeneity of the cancer and the potential for targeted radionuclide therapies based on these imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Poorly Differentiated Thyroid Cancer With Heterogeneous Distribution of 18F-FDG, 68Ga-DOTATATE, and 68Ga-PSMA on PET/CT. Civan, C., Isik, EG., Simsek, DH.[2023]

68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, highlighting its potential for better diagnosis compared to conventional imaging methods.

In two cases of esthesioneuroblastoma, 68 Ga-DOTATATE detected abnormal uptake that was not visible on 18F-FDG PET/CT, suggesting it may be crucial for treatment planning, including identifying candidates for targeted therapies like 177 Lu-DOTATATE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. Liu, KY., Goldrich, DY., Ninan, SJ., et al.[2021]

Gallium-68-dotatate PET/CT imaging demonstrated high sensitivity (94.16%) and specificity (91.89%) in detecting neuroendocrine tumors (NET) and other somatostatin expressing tumors, outperforming traditional CT scans.

In a study of 203 patients, PET/CT identified disease in 19 cases where CT was falsely negative, highlighting its superior ability to detect primary tumor sites and inform patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. Lawal, IO., Ololade, KO., Lengana, T., et al.[2019]

In a study involving 6 human subjects, (68)Ga-DOTATATE, a PET/CT imaging agent, showed no adverse events or toxicity, indicating its safety for use in imaging somatostatin receptor-expressing tumors.

The dosimetry results revealed that the spleen is the critical organ affected by (68)Ga-DOTATATE, with dosimetry levels similar to other (68)Ga-labeled somatostatin analogs, suggesting its potential for diagnosing and staging cancers like neuroendocrine tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measured human dosimetry of 68Ga-DOTATATE. Walker, RC., Smith, GT., Liu, E., et al.[2022]

Gallium-68 DOTA-peptide PET/CT is more sensitive and provides better spatial resolution for detecting tumors that express somatostatin receptors compared to traditional scintigraphy methods.

In a case study of a 12-year-old girl with primary neuroblastoma in the neck, Ga-68 DOTATATE PET/CT was effective in evaluating the tumor and assessing the response to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE positron emission tomography/computer tomography in initial staging and therapy response evaluation in a rare case of primary neuroblastoma in neck. Agrawal, K., Kumar, R., Shukla, J., et al.[2021]

The 68Ga-DOTATATE PET-CT scan was more effective than conventional imaging in detecting medullary thyroid cancer (MTC) recurrences or metastases in 37% of the 38 patients studied, identifying additional metastatic lymph nodes and bone metastases.

This imaging technique significantly influenced clinical management in 34% of patients, leading to interventions such as neck surgery and radiotherapy, highlighting its importance in the treatment planning for MTC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of 68Ga-DOTATATE PET-CT imaging in patients with medullary thyroid cancer. Tuncel, M., Kılıçkap, S., Süslü, N.[2022]

In a study of 97 patients with confirmed or suspected neuroendocrine tumors (NET), (68)Ga-DOTATATE PET/CT successfully identified lesions in 51.5% of cases, demonstrating its effectiveness in visualizing somatostatin receptor expression.

The technique was particularly useful in identifying primary tumor sites in patients with metastatic unknown primary cancer, highlighting its role in staging and planning targeted radionuclide therapy for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnostic role of 68Ga-DOTATATE PET/CT in the detection of neuroendocrine tumours. Łapińska, G., Bryszewska, M., Fijołek-Warszewska, A., et al.[2019]

(68)Ga-DOTATATE PET/CT scanning is a safe and effective imaging method for neuroendocrine tumors, with a high sensitivity of 97% and specificity of 95.1%, leading to changes in treatment plans for 40.9% of patients based on unexpected findings.

Survival outcomes significantly vary based on tumor grade, with lower-grade tumors (G1) associated with better prognosis compared to higher grades (G2 and G3), and the presence of bone metastasis correlating with worse overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of 68Ga-DOTATATE PET/CT Imaging on Management of Patients with Neuroendocrine Tumors: Experience from a National Referral Center in the United Kingdom. Skoura, E., Michopoulou, S., Mohmaduvesh, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

68Ga-DOTATOC PET/CT in Patients with Iodine- and 18F-FDG-Negative Differentiated Thyroid Carcinoma and Elevated Serum Thyroglobulin. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Incidental Detection of Medullary Thyroid Carcinoma by 68Ga-DOTATATE PET/CT in a Patient With Neuroendocrine Tumor Liver Metastases. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Metastatic Poorly Differentiated Thyroid Cancer With Heterogeneous Distribution of 18F-FDG, 68Ga-DOTATATE, and 68Ga-PSMA on PET/CT. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]

7. Greece pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Measured human dosimetry of 68Ga-DOTATATE. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE positron emission tomography/computer tomography in initial staging and therapy response evaluation in a rare case of primary neuroblastoma in neck. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

Clinical impact of 68Ga-DOTATATE PET-CT imaging in patients with medullary thyroid cancer. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

The diagnostic role of 68Ga-DOTATATE PET/CT in the detection of neuroendocrine tumours. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The Impact of 68Ga-DOTATATE PET/CT Imaging on Management of Patients with Neuroendocrine Tumors: Experience from a National Referral Center in the United Kingdom. [2022]