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

Overseen By Padmasree Veeraraghavan, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Disqualifiers: Pregnancy, Renal failure, Cardiac failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a compound called 68Gallium-DOTATATE can more effectively detect thyroid cancer using PET/CT scans. The focus is on thyroid cancers unresponsive to standard radioactive iodine treatment. Researchers hope the compound will highlight tumors, making them easier to spot in imaging. The trial seeks participants with thyroid cancer that has spread beyond the thyroid and who have not responded well to traditional treatments.

As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that 68-Gallium-DOTATATE-PET/CT imaging is safe for detecting thyroid cancer?

Research has shown that 68-Gallium-DOTATATE is generally safe for people. Studies in other conditions have found it well-tolerated. This substance aids PET/CT scans by helping doctors visualize certain tumors. Participants will receive a small amount of a radioactive tracer, a common practice in medical imaging that usually has few side effects. Although specific safety data for thyroid cancer is not detailed, its use in other situations supports its safety. Researchers will closely monitor participants in this trial to ensure their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard thyroid cancer treatments that often involve surgery, radioactive iodine, or chemotherapy, 68-Gallium-DOTATATE-PET/CT imaging offers a unique approach by using imaging rather than direct treatment. This method is exciting because it uses 68-Gallium-DOTATATE, which binds to specific receptors on thyroid cancer cells, allowing for more precise detection and staging of the disease. Researchers are hopeful that this advanced imaging technique will improve diagnosis accuracy and help tailor personalized treatment plans more effectively than current options.

What evidence suggests that 68-Gallium-DOTATATE-PET/CT is effective for detecting thyroid cancer?

Research has shown that 68-Gallium-DOTATATE-PET/CT effectively detects certain types of thyroid cancer. In this trial, participants with differentiated thyroid cancer (DTC) will undergo evaluation using this method, which has proven more accurate in identifying tumors than some other scans. Participants with Hurthle cell thyroid cancer (HTC) will also be assessed, as studies suggest it may better identify tumors by detecting more signals from affected areas. For those with medullary thyroid cancer (MTC), 68Ga-DOTATATE PET/CT has demonstrated superiority over regular scans in finding cancer that has spread to lymph nodes and bones. Overall, this imaging technique plays a crucial role in detecting and understanding thyroid tumors, potentially aiding in planning better treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Joanna Klubo-Gwiezdzinska, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

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 am unable to understand and give consent for my treatment.

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

Pregnancy or lactation by self-report

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 68-Gallium-DOTATATE-PET/CT

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

(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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12172355/

The utility of 68Ga-DOTATATE and 18F-FDG PET/CT in ... The utility of 68 Ga-DOTATATE and 18 F-FDG PET/CT in predicting the response to tyrosine kinase inhibitors in patients with advanced medullary thyroid cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04927416

NCT04927416 | The Role of 68-Gallium-DOTATATE-PET ... Background: About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6661311/

Diagnostic Efficiency of 68Ga-DOTATATE PET/CT as ... In our study, 68Ga-DOTATATE PET/CT was clearly superior to 99mTc-Octreotide SPECT/CT and CT/MRI showing increased sensitivity and specificity in patients with ...

4. withpower.com withpower.com/trial/phase-3-thyroid-neoplasms-9-2021-2809e

68-Gallium-DOTATATE-PET/CT Imaging for Thyroid Cancer For high-grade, poorly-differentiated NETs, both DOTATATE and FDG PET/CT scans were equally effective, with all patients showing positive results, indicating ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/57/1/34

The Impact of 68 Ga-DOTATATE PET/CT Imaging on ... Analysis of our data revealed that 68Ga-DOTATATE PET/CT led to a change in the scheduled treatment plan in 40.9% of patients. Management change ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X23007875

The Clinical Utility of Gallium-68-DOTATATE Positron ... Metastatic disease may be optimally assessed by concurrent 18F-FDG and 68Ga-DOTATATE imaging. Introduction. The prevalence of medullary thyroid cancer (MTC) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04927416?term=hurthle%20cell%20thyroid%20cancer&viewType=Table&rank=6

The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...