68Ga-PSMA PET Imaging for Gastrointestinal Cancer

(ERD2021 Trial)

Overseen By Amélie Tétu, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Disqualifiers: Other active cancer, ECOG > 3, pregnancy, 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

Approved in 3 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 explores a new method to assist individuals with upper GI cancers, such as those affecting the esophagus, stomach, bile ducts, or pancreas. Researchers use a special PET scan with 68Ga-PSMA (Gallium-68 PSMA-11) to determine if targeted radiation treatment (ERT) can be effective. This approach may offer fewer side effects and more precise treatment for metastatic cancer. Individuals with active adenocarcinoma, confirmed by a recent CT scan, might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 68Ga-PSMA PET imaging is safe for gastrointestinal cancer patients?

Research has shown that 68Ga-PSMA is generally safe for people. The FDA has already approved it for detecting certain cancer cells in prostate cancer patients, indicating it has been tested and found safe for this purpose. The procedure involves a small amount of radiation, which can slightly increase the risk of cancer over time. However, this risk remains very low. Overall, 68Ga-PSMA is well-tolerated, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for gastrointestinal cancer, which often rely on CT or MRI scans, 68Ga-PSMA PET imaging uses a novel tracer, 68Ga-PSMA, to enhance detection. This tracer specifically targets the PSMA protein, which is often overexpressed in cancer cells, allowing for more precise and sensitive imaging. Researchers are excited about this technique because it could lead to earlier and more accurate detection of cancer, potentially improving treatment outcomes for patients.

What evidence suggests that 68Ga-PSMA PET imaging is effective for gastrointestinal cancer?

Research has shown that 68Ga-PSMA PET imaging effectively detects cancer cells by targeting a protein often found in tumors. In this trial, all participants will undergo a PET scan with 68Ga-PSMA. One study found that 68Ga-PSMA PET/CT scans can predict the effectiveness of 177Lu-PSMA treatment by assessing cancer activity in the body. This scan is highly sensitive, capable of detecting even small amounts of cancer spread, particularly in prostate cancer. The imaging technique accurately identifies cancer growths, facilitating targeted treatment while protecting healthy tissues. Although direct data on upper GI cancers is limited, the ability to detect cancer cells suggests potential benefits for these patients. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Canada with advanced upper GI cancers, such as adenocarcinoma of the esophagus, stomach, bile ducts, or pancreas. Participants must have at least one stable or progressing tumor visible on a CT scan within the last 8 weeks and be able to undergo a special PET scan within 2 months of that CT scan. Those with poor performance status (ECOG >3), other active cancers except certain skin cancers, pregnant women, or inability to follow study protocols are excluded.

Inclusion Criteria

Able to provide free and informed consent.

I can have a 68Ga-PSMA PET scan within 2 months after my CT scan.

My scans show at least one cancer area not shrinking.

Exclusion Criteria

I do not have any active cancer except for non-metastatic skin cancer, or my cancer has been in remission for 3 years.

Pregnant woman.

Unable to follow study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo 68Ga-PSMA PET imaging to assess eligibility for 177Lu-PSMA treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and potential treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-PSMA

Trial Overview The trial is testing if patients with upper gastrointestinal cancer can use a new type of PET imaging using Radiopharmaceutical 68Ga-PSMA to see if they're eligible for targeted radiation therapy called Endoradiotherapy (ERT) with another agent called 177Lu-PSMA. This approach aims to deliver radiation directly to cancer cells while sparing healthy tissue.

How Is the Trial Designed?

Group I: Single arm with 68Ga-PSMA Experimental Treatment 1 Intervention

All participants will undergo a PET scan with 68Ga-PSMA

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Published Research Related to This Trial

The new radiopharmaceutical 68Ga-THP-PSMA is safe for use in patients with prostate cancer, showing no adverse events in a study involving 14 patients, and it effectively targets PSMA-expressing malignant tissue as confirmed by histopathology.

68Ga-THP-PSMA demonstrated a favorable biodistribution profile with lower background uptake compared to the previously used 68Ga-HBED-PSMA-11, which may enhance imaging clarity and facilitate rapid clinical adoption due to its simplified one-step production process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold Kit for Prostate-Specific Membrane Antigen (PSMA) PET Imaging: Phase 1 Study of 68Ga-Tris(Hydroxypyridinone)-PSMA PET/CT in Patients with Prostate Cancer. Hofman, MS., Eu, P., Jackson, P., 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]

A systematic review of 16 studies involving 1309 patients found that 68Ga-PSMA PET scans are highly effective in detecting metastatic prostate cancer, with a 76% positivity rate in patients with biochemical recurrence, especially as pre-PET PSA levels increase.

The overall sensitivity and specificity of 68Ga-PSMA PET were found to be 86% and 80% respectively, indicating that this imaging technique is more reliable than traditional choline-based PET imaging for assessing prostate cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Perera, M., Papa, N., Christidis, D., et al.[2022]

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]

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]

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 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]

The effective dose of [68Ga]PSMA-11 for imaging prostate cancer is 0.022 mSv/MBq, indicating a relatively low radiation exposure for patients.

In a study of six low-risk prostate cancer patients, the kidneys received the highest organ dose at approximately 40 mGy after a typical injection, while the eye lenses received a very low dose of 0.0051 mGy/MBq, suggesting a favorable safety profile for this imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. Sandgren, K., Johansson, L., Axelsson, J., et al.[2020]

A study involving 16 patients with prostate adenocarcinoma demonstrated that PET scans using 68Ga-PSMA produced from both cyclotron and generator methods are equivalent in detecting cancerous lesions, indicating reliable diagnostic performance.

The cyclotron method can produce larger quantities of 68Ga, which may lower production costs and improve availability of this important radiotracer for prostate cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclotron vs generator-produced 68Ga PSMA: a single-institution, prospective clinical trial. Martinez, J., Subramanian, K., Huicochea Castellanos, S., et al.[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]

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 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]

Citations

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

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ... In a study by Afshar-Oromieh et al. on the dosimetry of PSMA-11 PET, it was found that the mean effective dose of a [68Ga]Ga-PSMA-11 PET scan is 0.023 mSv/MBq, ...

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

Quantitative 68 Ga-PSMA-11 PET and Clinical Outcomes ... 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. nature.com nature.com/articles/s41391-023-00755-2

Comparison of 18 F-based PSMA radiotracers with [ 68 Ga ... This study aims to investigate whether Fluorine-18 ( 18 F)-labelled PSMA PET/CT is significantly different from Gallium-68 ( 68 Ga) in primary diagnosis and/or ...

4. onclive.com onclive.com/view/64cu-sar-bispsma-bests-soc-68ga-psma-11-pet-ct-in-detecting-psma-positive-prostate-cancer-lesions

64Cu-SAR-bisPSMA Bests SOC 68Ga-PSMA-11 PET/CT ... 64Cu-SAR-bisPSMA outperformed 68Ga-PSMA-11 PET/CT in detecting PSMA-positive lesions in low PSA level patients, achieving the Co-PSMA trial's ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.18.20699

Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET ... Conclusion. Gallium-68-labeled PSMA-11 PET has high sensitivity for prostate cancer metastases in patients with biochemically recurrent prostate cancer.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.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 patients with prostate cancer, although the number of adult ...

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

Gallium ga 68 psma-11 (intravenous route) - Side effects & ... While receiving this medicine, you will be exposed to radiation and increase risk of cancer. If you have any questions about this, talk to ...

8. go.drugbank.com go.drugbank.com/drugs/DB16019

Ga 68 PSMA-11: Uses, Interactions, Mechanism of Action Ga 68 PSMA-11 is a radiopharmaceutical agent used in the diagnosis of prostate-specific membrane antigen (PSMA) positive lesions in male ...