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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scan called 68Gallium PSMA-PET/CT to determine if it can better detect cancer in individuals with metastatic bladder or skin cancer. The goal is to assess whether this scan performs better, the same, or worse than the usual scans doctors use. Suitable participants include those with metastatic bladder cancer that has spread beyond the pelvis or those with metastatic melanoma with at least one detectable lesion. The trial aims to enhance how doctors visualize cancer in the body, potentially leading to better treatment decisions. As a Phase 1 trial, this research focuses on understanding how the scan functions in people, offering participants the opportunity to be among the first to benefit from this innovative technology.

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 prior data suggests that the 68Ga PSMA-PET/CT scan is safe for detecting cancer?

Research has shown that 68Ga PSMA-PET/CT scans are generally easy for patients to handle. In past studies, patients reported no serious side effects related to the treatment. For example, a study on 68Ga-PSMA-R2 found no negative reactions linked to the drug, indicating its safety for imaging. Additionally, the FDA has approved 68Ga-PSMA-11, a similar substance, for certain cancer imaging, providing reassurance about its safety. This approval means the treatment has undergone careful review and is accepted for use in other conditions, highlighting its overall safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 68Ga PSMA-PET/CT scan technique because it offers a new way to visualize and assess bladder cancer, potentially improving the accuracy of cancer detection. Unlike traditional imaging methods like FDG PET or CT scans, this technique uses a radioactive tracer, 68Gallium, that specifically targets the Prostate-Specific Membrane Antigen (PSMA), which is often found in higher levels on cancer cells. This targeted approach could lead to more precise imaging of metastatic lesions, helping doctors better understand the extent of cancer spread and make more informed treatment decisions.

What evidence suggests that the 68Ga PSMA-PET/CT scan is effective for detecting metastatic bladder cancer or skin cancer?

Research shows that 68Gallium PSMA-PET/CT scans are being tested to detect cancer, particularly in the bladder and skin. In this trial, participants with melanoma lesions and metastatic urothelial carcinoma lesions will undergo these scans. Earlier studies primarily focused on prostate cancer and found this method effective in identifying cancerous areas. Although these scans appear promising for certain cancers, they are still being compared to the more common FDG-PET/CT scans to determine if they provide clearer or more accurate images. So far, evidence suggests that 68Gallium PSMA-PET/CT has potential, but more research is needed to confirm its effectiveness specifically for bladder and skin cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Gopakumar Iyer, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Patient must be able to understand and is willing to sign a written informed consent document

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

[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]

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]

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]

(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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37477778/

Head-to-head comparisons of 68 Ga-PSMA-11 and 18 F- ...

Conclusion: 18F-FDG PET/CT holds better clinical potential for evaluating UTUC and detecting lymph node metastasis compared to 68Ga-PSMA-11 PET/ ...

2.

urotoday.com

urotoday.com/conference-highlights/esmo-2025/esmo-2025-prostate-cancer/164075-esmo-2025-associations-between-quantitative-baseline-68ga-psma-11-pet-parameters-and-177lu-psma-617-efficacy-in-the-psmafore-study.html

ESMO 2025: Associations Between Quantitative Baseline ...

Herrmann and colleagues assessed associations between baseline quantitative PSMA PET parameters and efficacy outcomes. PSMA-positive mCRPC was defined as ≥1 ...

3.

cancer.gov

cancer.gov/clinicaltrials/NCI-2022-08457

A Study of 68Gallium PSMA-PET/CT Scans in Patients with ...

The PET/CT scanner detects the radioactivity from radiotracers and takes images of the cancer. This study may help to determine if 68Gallium PSMA-PET/CT scan ...

4.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1216894/full

68 Ga-PSMA-11 PET/CT versus 68 ...

The diagnostic efficacy of 68 Ga-PSMA-11 PET/CT appears to be equivalent to that of 68 Ga-PSMA-11 PET/MRI in detecting biochemically recurrent prostate cancer.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5740783/

68Ga PSMA-11 PET with CT urography protocol in the ...

The study presents a novel protocol of 68Ga-PSMA-11 PET/CT-U in PS and BCR of PC. Methods. A retrospective review of PSMA PET/CT-U preformed on ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ...

On 1 December 2020, almost 10 years after its discovery, [68Ga]Ga-PSMA-11 was approved by the Food and Drug Administration (FDA) [1] as the first 68Ga-labeled ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use

Ga 68 PSMA-11 Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate ...

8.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/3/359

Safety, Dosimetry, and Feasibility of [68Ga]Ga-PSMA-R2 as ...

68 Ga-PSMA-R2 was well tolerated, with no drug-related treatment-emergent adverse events. Safety and preliminary imaging performance data support further ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2405456921001966

Urothelial Carcinoma and Prostate-specific Membrane ...

PSMA PET imaging may improve detection of metastatic disease and response to systemic therapy due to PSMA expression in neovasculature.

10.

ajronline.org

ajronline.org/doi/10.2214/AJR.19.21084

Gallium-68–Labeled Prostate-Specific Membrane Antigen ...

This article summarizes current published studies of 68 Ga-PSMA-11 PET/CT evaluation of prostate and nonprostate malignancies as well as a few benign ...