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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to evaluate treatment effectiveness for metastatic adenoid cystic carcinoma, a specific type of salivary gland cancer that has spread. The trial employs a special imaging technique that combines PET and CT scans to create detailed internal images. Ga-68 PSMA-11, a radiotracer, enhances this imaging process. The goal is to determine if this method can better detect cancer changes post-treatment, aiding doctors in making informed decisions. Suitable candidates for this trial include those diagnosed with metastatic adenoid cystic carcinoma who can undergo these scans and are willing to return for a follow-up scan after about 12-20 weeks. As a Phase 2 trial, this research measures treatment effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

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 prior data suggests that this imaging technique is safe for detecting therapy response in metastatic adenoid cystic carcinoma?

Research has shown that Ga-68 PSMA-11 is generally safe and well-tolerated by patients. Studies have found no major side effects linked to this drug. One study used Ga-68 PSMA-11 for imaging and found its safety profile similar to other imaging agents, with most people not experiencing serious side effects from the injection. Overall, evidence suggests that Ga-68 PSMA-11 is safe for use in medical imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ga-68 PSMA-11 because it offers a novel approach to imaging prostate cancer. Unlike traditional imaging methods, Ga-68 PSMA-11 is a radioactive tracer specifically targeting the Prostate-Specific Membrane Antigen (PSMA) found on prostate cancer cells, potentially providing clearer and more accurate scans. This precise targeting could help detect cancer spread earlier and more effectively, which is crucial for planning the best treatment strategies. Additionally, the use of PET/CT scans with this tracer might enhance the detection of even small cancerous lesions, offering a significant advantage over existing imaging techniques.

What evidence suggests that Ga-68 PSMA-11 PET/CT is effective for detecting treatment response in metastatic adenoid cystic carcinoma?

Research shows that Ga-68 PSMA-11 PET/CT scans effectively locate where cancer has spread. Studies have found that these scans identify cancer locations in 94% of prostate cancer patients. In this trial, participants will undergo Ga-68 PSMA-11 PET/CT scans, which might also help detect the spread of adenoid cystic carcinoma. The scan uses a small amount of a radioactive substance to highlight cancer cells in the images, aiding doctors in determining the best treatment options. ^{6 7 8 9 10}

Who Is on the Research Team?

Brian J. Burkett, MD, MPH

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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

Enrolled in protocol MC200708

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.

Exclusion Criteria

Unable to undergo PET/CT scan

Not a participant in MC200708

Persons who are pregnant or nursing

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39162634/

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ...

Baseline 68 Ga-PSMA-11 PET/CT whole-body tumor SUV mean was the best predictor of 177 Lu-PSMA-617 efficacy in participants in the VISION trial.

2.

pubs.rsna.org

pubs.rsna.org/doi/abs/10.1148/radiol.233460

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ...

Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial.

3.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/supplement_1/251888

Impact of 68Ga-PSMA-11 PET/CT on Clinical Management of ...

68 Ga-PSMA-11 PET/CT is a promising diagnostic tool in the work-up of PCa patients in the real world, demonstrating an overall positivity rate of 94%.

4.

nature.com

nature.com/articles/s41598-024-65399-1

Comparison of digital and analog [68Ga]Ga-PSMA-11 PET ...

This prospective study compared the diagnostic performances of digital and analog [ 68 Ga]Ga-PSMA-11 PET/CT in patients who experienced BCR after prostatectomy.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0720048X23005880

68Ga-prostate specific membrane antigen-11 PET/CT ...

This meta-analysis concludes that both 68 Ga-PSMA-11 PET/CT and mpMRI have similar diagnostic performance in detecting primary prostate cancer.

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/212643s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use

The efficacy and safety profiles of Ga 68 PSMA-11 Injection appear similar in adult and geriatric ... Each patient received a single Ga 68 PSMA-11 PET/CT or. PET/ ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8612191/

A Phase II, Open-Label Study to Assess Safety and ...

This phase II, open-label prospective clinical trial showed 68 Ga-THP PSMA PET/CT to be well tolerated and safe to use.

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/57/NCT05197257/Prot_SAP_ICF_000.pdf

68Ga-PSMA-11 PET in Patients with Prostate Cancer

AEs will be collected during injection and uptake phase (50-100 min) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 ...

9.

jnm.snmjournals.org

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

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

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

10.

mayoclinic.org

mayoclinic.org/drugs-supplements/gallium-ga-68-psma-11-intravenous-route/description/drg-20506366

Gallium ga 68 psma-11 (intravenous route) - Mayo Clinic

Gallium Ga 68 PSMA-11 injection is used with a PET scan (positron ... Safety and efficacy have not been established. Use of gallium Ga ...