Ga-68 PSMA-11 PET/CT Scan for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnant, Nursing, Under 18, 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

Compensation: Varies

Number of Visits: 2

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ga-68 PSMA-11 PET/CT Scan for Cancer?

Research shows that Ga-68 PSMA-11 PET/CT scans are effective in detecting prostate cancer recurrence and influencing treatment decisions. In a study, it led to management changes in more than half of the patients with recurrent prostate cancer, helping doctors better target their treatment plans. ^{1 2 3 4 5}

Is Ga-68 PSMA-11 PET/CT scan safe for humans?

Ga-68 PSMA-11 PET/CT scans have been shown to be safe in humans, with no serious adverse events reported in studies. Some minor side effects like itching and rash at the injection site have been noted, but no participants had to stop the study due to these effects. ^{6 7 8 9 10}

How is the Ga-68 PSMA-11 PET/CT scan different from other treatments for prostate cancer?

The Ga-68 PSMA-11 PET/CT scan is unique because it uses a special tracer to create detailed images of prostate cancer, helping to detect relapses and metastases with high accuracy. Unlike traditional imaging methods, this scan provides a clearer picture of cancer spread, which can improve diagnosis and treatment planning. ^{6 8 9 11 12}

What is the purpose of this trial?

This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.

Research Team

Brian J. Burkett, MD, MPH

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for patients with adenoid cystic carcinoma, a type of salivary gland cancer that has spread to other body parts. The eligibility criteria are not fully listed but typically include factors like the stage of cancer, prior treatments received, and overall health status.

Inclusion Criteria

Willingness to return for a second PSMA PET/CT scan in approximately 12-20 weeks from the baseline PET/CT

I have been diagnosed with metastatic adenoid cystic carcinoma.

Enrolled in protocol MC200708

Exclusion Criteria

Unable to undergo PET/CT scan

Not a participant in MC200708

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive Ga-68 PSMA-11 IV and undergo baseline PET/CT imaging

1 day

1 visit (in-person)

Investigational Therapy

Participants undergo PET/CT imaging approximately 12-20 weeks during investigational therapy

12-20 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

Treatment Details

Interventions

• Ga-68 PSMA-11

Trial Overview The trial is testing if a new scan using Ga-68 PSMA-11 PET/CT can effectively detect how well treatment is working in patients with metastatic adenoid cystic carcinoma. It combines radioactive imaging and x-ray technology to create detailed images of the body's response to therapy.

Participant Groups

Group I: Diagnostic (Ga-68 PSMA-11, PET/CT) Experimental Treatment 4 Interventions

Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The 68Ga-PSMA-11 PET/CT imaging technique demonstrated a detection rate of 53.6% for identifying prostate cancer relapse in 332 patients, with varying effectiveness based on the clinical stage of biochemical recurrence (BCR).

The positive predictive value (PPV) of 68Ga-PSMA-11 PET/CT was very high at 96.2%, indicating its reliability in detecting local versus systemic disease in patients with rising PSA levels after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT in recurrent prostate cancer: efficacy in different clinical stages of PSA failure after radical therapy. Ceci, F., Castellucci, P., Graziani, T., et al.[2021]

In a study of 25 patients with untreated intermediate- and high-risk prostate cancer, [68Ga]-PSMA PET/CT demonstrated high diagnostic sensitivity, successfully detecting cancer in all participants and revealing metastatic disease in various locations, including lymph nodes and bones.

The maximum standardized uptake value (SUVmax) of the primary tumor was significantly correlated with serum PSA levels, suggesting that higher SUVmax values may indicate more advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Study on [68Ga]-PSMA PET/CT Imaging in Newly Diagnosed Intermediate- and High-Risk Prostate Cancer. Harsini, S., Fallahi, B., Karamzade Ziarati, N., et al.[2022]

In a study of 113 patients with prostate cancer, 68Ga-PSMA PET/CT demonstrated significantly higher sensitivity (96.2%) and accuracy (99.1%) for detecting skeletal metastases compared to traditional bone scintigraphy (73.1% sensitivity and 84.1% accuracy).

68Ga-PSMA PET/CT not only identified more bone lesions (91 vs. 61) but also revealed an additional 96 unexpected extraskeletal lesions, highlighting its superior capability in detecting both lytic and bone marrow metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli? Lengana, T., Lawal, IO., Boshomane, TG., et al.[2021]

The preparation of [(68)Ga]PSMA-11 for PET-CT imaging in prostate cancer patients resulted in consistently high radiochemical yields of 93.19%±3.76%, with over 200 batches produced and no batch failures reported.

The radiopharmaceutical demonstrated high radiochemical purity (>99%) and was well-tolerated by over 300 patients, with no adverse reactions observed, indicating its safety and efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. Nanabala, R., Anees, MK., Sasikumar, A., et al.[2021]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

Ga-PSMA-11 is a promising PET tracer for imaging advanced prostate cancer, showing specific uptake patterns in various organs, which helps in understanding its biodistribution and potential physiological variants.

The study identified normal uptake in the prostate and other organs, as well as benign lesions, which is crucial for avoiding misinterpretations during scans and ensuring accurate diagnosis in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. Demirci, E., Sahin, OE., Ocak, M., et al.[2022]

[68Ga]Ga-PSMA-11 is a key radiopharmaceutical used for imaging prostate-specific membrane antigen (PSMA), which is crucial for managing recurrent prostate cancer.

The paper provides a comprehensive overview of the preclinical development and clinical applications of [68Ga]Ga-PSMA-11, comparing its effectiveness with other imaging methods to guide clinicians in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Bois, F., Noirot, C., Dietemann, S., et al.[2020]

68Ga-PSMA-11 PET/CT has quickly become a valuable tool in prostate cancer imaging, showing high potential for primary diagnosis, staging, and monitoring biochemical recurrence based on numerous studies.

The review aims to summarize key data on 68Ga-PSMA-11 PET/CT and provide recommendations for its use in clinical practice, highlighting its effectiveness in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? Uprimny, C.[2021]

In a study of 188 patients with rising PSA levels after prostate cancer treatment, 68Ga-PSMA PET/CT demonstrated a high detection rate of 87.8% for tumor relapse, identifying local recurrences and metastases effectively.

The diagnostic accuracy of 68Ga-PSMA PET/CT was exceptional, with sensitivity and specificity rates of 98.8% and 100%, respectively, making it a highly reliable tool for monitoring prostate cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. Hamed, MAG., Basha, MAA., Ahmed, H., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT in recurrent prostate cancer: efficacy in different clinical stages of PSA failure after radical therapy. [2021]

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

Impact of 68Ga-PSMA-11 PET on the Management of Recurrent Prostate Cancer in a Prospective Single-Arm Clinical Trial. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

A Prospective Study on [68Ga]-PSMA PET/CT Imaging in Newly Diagnosed Intermediate- and High-Risk Prostate Cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. [2022]

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

68Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli? [2021]

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

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. [2021]

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

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic studies of [68 Ga]Ga-PSMA-11 in patients with biochemical recurrence of prostate cancer: detection, differences in temporal distribution and kinetic modelling by tissue type. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. [2022]

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

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. [2020]

11. Austria pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? [2021]

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

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. [2021]