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

Trial Summary

What is the purpose of this trial?

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 of PET imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. 68Ga-DOTATATE digital PET/CT may work better in imaging patients with soft tissue sarcomas.

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 data supports the effectiveness of the treatment 68Ga-DOTATATE PET/CT for Soft Tissue Sarcoma?

The research shows that 68Ga-DOTATATE PET/CT is effective in identifying and managing neuroendocrine tumors by helping doctors make better treatment decisions, with 50% of management changes being implemented. This suggests it could be useful in other types of tumors, like soft tissue sarcoma, by providing detailed imaging to guide treatment. ^{1 2 3 4 5}

Is 68Ga-DOTATATE generally safe for use in humans?

68Ga-DOTATATE has been used safely in humans for imaging neuroendocrine tumors, with no significant safety concerns reported in the studies reviewed. It is a radiolabeled imaging agent that targets specific receptors in tumors, and its use in imaging has been well-established. ^{1 3 6 7 8}

How is the drug 68Ga-DOTATATE unique for treating soft tissue sarcoma?

68Ga-DOTATATE is unique because it is a PET/CT imaging agent that targets somatostatin receptors, which are often present in neuroendocrine tumors. This allows for precise imaging and localization of tumors, which is different from traditional treatments that may not specifically target these receptors. ^{1 3 6 9 10}

Research Team

Gabriel R. Tinoco Suarez

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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 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]

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]

References

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

Post FDA approval analysis of 200 gallium-68 DOTATATE imaging: A retrospective analysis in neuroendocrine tumor patients. [2023]

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

Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. [2020]

3. 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]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic Evaluation of Metastatic Castration Resistant Prostate Cancer and Neuroendocrine Prostate Cancer with [68Ga]Ga DOTATATE 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. 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]

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

Unusual Increased Blood Pool Activity on 68Ga-DOTATATE PET/CT in a Patient With Metastatic Neuroendocrine Disease. [2023]

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

68Ga-DOTATATE Uptake in a Soft Tissue Metastasis From Clear Cell Renal Cell Cancer. [2019]