68Ga PSMA-PET/CT Scan for Bladder Cancer

Overseen By Michael Morris, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Bone only disease, 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: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer or skin cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer or skin cancer (FDG-PET/CT scan).

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment 68Ga-PSMA-11 for bladder cancer?

The 68Ga-PSMA-11 PET/CT scan has shown promise in detecting prostate cancer, including cases where cancer has spread to the bladder, by highlighting cancerous areas more clearly than the surrounding tissue. This suggests it might be useful in identifying bladder cancer as well. ^{1 2 3 4 5}

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

The 68Ga PSMA-PET/CT scan has been shown to be generally safe in humans, with no serious adverse events reported in studies involving prostate cancer patients. Some minor side effects like itching and rash at the injection site were noted, but no participants had to leave the study because of these effects. ^{6 7 8 9 10}

How does the 68Ga PSMA-PET/CT scan treatment for bladder cancer differ from other treatments?

The 68Ga PSMA-PET/CT scan is unique because it uses a radiotracer that targets prostate-specific membrane antigen (PSMA), which can help in detecting cancer spread more clearly, especially in bone metastases, compared to traditional imaging methods. This approach is particularly novel for bladder cancer, as PSMA imaging is primarily used for prostate cancer, offering a new way to visualize and assess the disease. ^{1 5 8 11 12}

Research Team

Gopakumar Iyer, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with metastatic bladder cancer, specifically urothelial carcinoma that has spread beyond the pelvis. Participants must have at least three lesions visible on standard PET/CT scans and be in a condition where they can perform daily activities (Karnofsky performance status ≥50%). Pregnant women, patients on other clinical trials or those with only bone disease are excluded.

Inclusion Criteria

My cancer has spread beyond the pelvic area to organs like the lung, liver, or bones.

I can do most of my daily activities by myself.

I am 18 years old or older.

Exclusion Criteria

I cannot stay still or lie flat for a PET scan.

You are currently participating in another medical treatment study.

I am being closely monitored for cancer that is not urothelial cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 68Gallium PSMA-PET/CT and standard of care imaging (FDG PET or CT scan)

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• [68Ga]PSMA

Trial Overview The study is testing if 68Gallium PSMA-PET/CT scans are more effective than the usual FDG-PET/CT scans for detecting cancer sites in people with metastatic bladder cancer. It aims to determine whether this new type of scan provides better imaging results.

Participant Groups

Group I: Patients with metastatic urothelial carcinoma lesions Experimental Treatment 2 Interventions

Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.

Group II: Patients with melanoma lesions Experimental Treatment 2 Interventions

Patients with melanoma who have 1 or more radiographically assessable metastatic lesions on standard of care imaging will undergo a 68Gallium PSMA-PET/CT and standard of care imaging (either FDG PET or CT scan).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Early dynamic imaging using 68Ga-PSMA-11 PET/CT can effectively differentiate between cancer-related tracer uptake and normal physiological accumulation in the urinary bladder, enhancing the accuracy of prostate cancer diagnosis.

In a study of 80 prostate cancer patients, the use of early dynamic imaging increased the detection rate of local recurrence from 20.3% to 29.7%, indicating its potential to improve patient outcomes in cases of biochemical relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early dynamic imaging in 68Ga- PSMA-11 PET/CT allows discrimination of urinary bladder activity and prostate cancer lesions. Uprimny, C., Kroiss, AS., Decristoforo, C., et al.[2022]

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]

The study of 57 prostate cancer patients demonstrated that the novel 68Ga-PSMA-11 PET/CT-U protocol significantly aids in differentiating between true cancerous activity and radioactive urine, improving interpretation of PET scans.

In the biochemical relapse group, 72% of patients had positive PSMA PET results, while the PET/CT-U helped clarify 17.5% of equivocal findings, indicating its potential to enhance diagnostic accuracy in prostate cancer staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga PSMA-11 PET with CT urography protocol in the initial staging and biochemical relapse of prostate cancer. Iravani, A., Hofman, MS., Mulcahy, T., et al.[2021]

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]

In a case study of a 77-year-old man with prostate cancer, the 68Ga-PSMA-11 PET/CT imaging demonstrated that a suspected bladder wall metastasis showed significantly increased uptake of the tracer over time, indicating its potential for better detection of cancerous lesions.

The dual-time point imaging (60 and 110 minutes post-injection) improved the contrast of the lesion against the urine background, suggesting that delayed imaging can enhance the accuracy of identifying metastases in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Time Point for 68Ga-PSMA-11 PET/CT Imaging in the Assessment of Suspected Metastatic Prostate Cancer in the Bladder of Postprostatectomy Patient. Xu, G., Lu, Y.[2023]

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]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

In a study involving 88 patients with prostate cancer, the Ga-PSMA-11 ligand for PET/CT imaging showed no reported clinical adverse events, indicating a strong safety profile for this imaging agent.

While there were significant decreases in systolic blood pressure and heart rate over time, these changes were minimal and did not lead to any cases of hypotension, confirming that Ga-PSMA-11 is well tolerated in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Safety Evaluation of 68Ga-Labeled Ligand Prostate-Specific Membrane Antigen 11 PET/CT in Prostate Cancer: The Results of 2 Prospective, Multicenter Trials. Nielsen, JB., Zacho, HD., Haberkorn, U., et al.[2021]

[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]

In a case study of urothelial carcinoma of the bladder with bone metastases, PSMA PET/MRI provided clearer imaging of bone metastases compared to traditional FDG PET/CT.

The bone metastases exhibited varying levels of uptake on both imaging techniques, with PSMA PET/MRI showing moderate to intense uptake, indicating its potential efficacy in detecting and delineating metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-Specific Membrane Antigen-Avid Bone Metastases From Urothelial Carcinoma of the Bladder. Zhao, B., Dong, A., Zuo, C.[2023]

Gallium-68 (68Ga) PSMA PET imaging is emerging as a valuable tool for detecting prostate cancer metastases, even in patients with low prostate-specific antigen levels, addressing limitations of conventional imaging methods.

To effectively interpret 68Ga-PSMA PET/CT results, medical professionals need to understand the normal uptake patterns and potential pitfalls associated with this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68 Prostate-Specific Membrane Antigen PET Imaging. Hofman, MS., Iravani, A.[2018]

References

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

Early dynamic imaging in 68Ga- PSMA-11 PET/CT allows discrimination of urinary bladder activity and prostate cancer lesions. [2022]

2. Austria pubmed.ncbi.nlm.nih.gov

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

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

68Ga PSMA-11 PET with CT urography protocol in the initial staging and biochemical relapse of prostate cancer. [2021]

4. 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]

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

Optimal Time Point for 68Ga-PSMA-11 PET/CT Imaging in the Assessment of Suspected Metastatic Prostate Cancer in the Bladder of Postprostatectomy Patient. [2023]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. [2022]

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

A Comprehensive Safety Evaluation of 68Ga-Labeled Ligand Prostate-Specific Membrane Antigen 11 PET/CT in Prostate Cancer: The Results of 2 Prospective, Multicenter Trials. [2021]

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

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

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

Prostate-Specific Membrane Antigen-Avid Bone Metastases From Urothelial Carcinoma of the Bladder. [2023]

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

Gallium-68 Prostate-Specific Membrane Antigen PET Imaging. [2018]