68Ga-DOTATATE PET/CT for Soft Tissue Sarcoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Somatostatin analogs

Disqualifiers: Pregnancy, Incarceration, Acute infections, others

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

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new imaging technique using a radiotracer called 68Ga-DOTATATE (also known as Gallium Ga 68-HA-DOTA-TATE) can diagnose soft tissue sarcoma, a type of cancer. The research aims to determine if this method provides clearer images of the cancer than current techniques. Participants will receive the radiotracer and undergo special imaging sessions to assess whether this approach improves diagnosis. Individuals diagnosed with any stage of soft tissue sarcoma and who have recently had a standard PET/CT scan might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative diagnostic advancements in cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have used somatostatin long-acting analogs in the past 6 months, you cannot participate.

What prior data suggests that 68Ga-DOTATATE PET/CT is safe for diagnosing soft tissue sarcoma?

Research has shown that 68Ga-DOTATATE is safe for use in imaging tests. Studies on neuroendocrine tumors found no major safety issues. This substance enhances PET scan clarity and requires only a small amount of radioactivity. Used for over ten years, it holds respect in the medical field. Overall, evidence suggests that 68Ga-DOTATATE is well-tolerated and poses minimal risk when used in imaging, as in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Gallium Ga 68-HA-DOTA-TATE for soft tissue sarcoma because it offers a new way to visualize tumors. Unlike traditional imaging techniques, this approach uses a radioactive tracer that specifically targets somatostatin receptors, often found in these tumors. This method could provide clearer images of the tumor's size and spread, helping doctors make more informed treatment decisions. Additionally, it might allow for earlier and more accurate detection compared to existing methods, potentially improving patient outcomes.

What evidence suggests that 68Ga-DOTATATE PET/CT is effective for diagnosing soft tissue sarcoma?

Research has shown that 68Ga-DOTATATE PET/CT imaging effectively detects tumors and cancer spread in certain neuroendocrine tumors. Studies have demonstrated its high accuracy in identifying the presence of these tumors. While primarily used for neuroendocrine tumors, early research suggests that 68Ga-DOTATATE might also enhance imaging for soft tissue sarcomas by providing clearer pictures. In this trial, participants will receive 68Ga-DOTATATE intravenously and undergo PET/CT imaging to evaluate its effectiveness in soft tissue sarcomas. This could help doctors better understand the extent of cancer spread in the body. Overall, 68Ga-DOTATATE is considered a promising tool for diagnosing and managing certain types of cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Gabriel R. Tinoco Suarez

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with soft tissue sarcoma. Participants should be suitable candidates for PET/CT imaging and have no health conditions that would interfere with the use of the radiotracer 68Ga-DOTATATE or the imaging process.

Inclusion Criteria

I have been diagnosed with soft tissue sarcoma at any stage and am a candidate for systemic therapies.

Patients with one standard of care PET/CT scan up to 30 days before enrollment at the Ohio State University facilities.

Exclusion Criteria

Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

I have used somatostatin analogs in the last 6 months.

Pregnant or lactating patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients receive gallium Ga 68-HA-DOTA-TATE intravenously and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging, including the incidence of adverse events.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Gallium Ga 68-HA-DOTA-TATE

Trial Overview The trial is testing how effective a new type of digital PET/CT scan using a radiotracer called 68Ga-DOTATATE is in diagnosing soft tissue sarcomas, potentially offering clearer images than current methods.

How Is the Trial Designed?

Group I: Diagnostic (68Ga-DOTATATE dPET/CT) Experimental Treatment 3 Interventions

Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes..

Gallium Ga 68-HA-DOTA-TATE is already approved in United States, European Union for the following indications:

Approved in United States as NETSPOT for:

• Neuroendocrine tumors
• Somatostatin receptor-positive neuroendocrine tumors

Approved in European Union as 68Ga-DOTATATE for:

• Neuroendocrine tumors
• Somatostatin receptor-positive neuroendocrine tumors

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

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]

In a patient with a well-differentiated stage IV neuroendocrine tumor, there was an unusual case of increased blood pool uptake of 68Ga-DOTATATE, which could affect the accuracy of treatment response assessments during PET/CT scans.

This transient increase in blood pool accumulation of 68Ga, likely due to unbound radiopharmaceutical, highlights the need for careful interpretation of PET/CT results to avoid misleading conclusions about treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual Increased Blood Pool Activity on 68Ga-DOTATATE PET/CT in a Patient With Metastatic Neuroendocrine Disease. Sharma, A., Navaz, AJ., Pandey, MK., et al.[2023]

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]

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 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]

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]

In a study of 130 patients with neuroendocrine tumors, 68Ga-DOTATATE PET/CT imaging led to intended management changes in 50% of cases, highlighting its significant clinical impact on treatment decisions.

Of the intended management changes, 75% were actually implemented within six months, demonstrating not only the effectiveness of the imaging technique but also its practical application in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. Calais, J., Czernin, J., Eiber, M., et al.[2020]

In a study of 17 patients with metastatic castration-resistant prostate cancer (mCRPC) and neuroendocrine prostate cancer (NePC), [68Ga]Ga-DOTATATE PET-CT successfully identified metastatic lesions, indicating its utility for staging these cancers.

Patients with marked [68Ga]Ga-DOTATATE uptake had poor outcomes, with all non-responders to treatment dying within an average of 8.1 months, while those with mild uptake were responders and survived for at least 36 months, suggesting that higher uptake may indicate worse prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic Evaluation of Metastatic Castration Resistant Prostate Cancer and Neuroendocrine Prostate Cancer with [68Ga]Ga DOTATATE PET-CT. Bilen, MA., Akintayo, A., Liu, Y., et al.[2023]

Gallium-68 DOTATATE imaging effectively identified the primary tumor site in 45% of patients with neuroendocrine tumors (NETs) of unknown primary origin, highlighting its utility in disease localization.

The study found that systemic exposure to long-acting somatostatin analogs did not significantly affect the mean Standardized Uptake Value (SUV) in gallium-68 DOTATATE scans, suggesting that these treatments do not compromise imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post FDA approval analysis of 200 gallium-68 DOTATATE imaging: A retrospective analysis in neuroendocrine tumor patients. Chauhan, A., El-Khouli, R., Waits, T., et al.[2023]

Ga-DOTATATE PET/CT imaging can effectively identify metastatic lesions in patients with clear cell renal cell cancer, as demonstrated in a 64-year-old man with a significant uptake in a soft tissue lesion.

The cytopathology confirmed that the lesion was indeed a metastasis from clear cell renal cell cancer, highlighting the utility of Ga-DOTATATE imaging in tracking cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE Uptake in a Soft Tissue Metastasis From Clear Cell Renal Cell Cancer. Vamadevan, S., Le, K., Shen, L., et al.[2019]

Citations

1. trialx.com trialx.com/clinical-trials/listings/319313/68ga-dotatate-petct-for-the-diagnosis-of-soft-tissue-sarcomas/

68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue ... This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve ...

2. withpower.com withpower.com/trial/phase-soft-tissue-sarcoma-sts-7-2024-da5b1

68Ga-DOTATATE PET/CT for Soft Tissue Sarcoma 68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23928010/

Diagnostic role of Gallium-68 DOTATOC and ... The molecular imaging agents 68Ga-DOTATOC and 68Ga-DOTATATE demonstrated high sensitivity and specificity in the diagnosis of NETs on PET scan.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-11528

68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue ... This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.18.19881

Neuroendocrine Tumor Diagnosis and Management: 68 Ga ... Gallium-68 DOTATATE PET/CT has good diagnostic accuracy to detect distant metastases and can have significant impact on patient management (Fig. 3). The liver ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362940/

Safety and Efficacy of 68Ga-DOTATATE PET/CT ... Our purpose was to evaluate safety and efficacy of 68 Ga-DOTATATE PET/CT compared with 111 In-pentetreotide imaging for diagnosis, staging, and restaging

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06500065/68ga-dotatate-pet-ct-for-the-diagnosis-of-soft-tissue-sarcomas

68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue ... This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality ...

8. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/gallium-dotatate-ga-68

Gallium Dotatate Ga 68 - an overview Gallium-68 (t 1/2 = 68 m, 89% β+) has gained significant prominence over the last decade with two gallium-68 labeled radiopharmaceuticals.

9. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2022.825486/full

Normal Variants, Pitfalls and Artifacts in Ga-68 DOTATATE ... 68Ga-DOTATATE images typically show very low background activity in the soft tissues thus yielding high target to background images. A so-called “sink ...