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

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 68Ga-PSMA PET Imaging for gastrointestinal cancer?

While there is no direct evidence for gastrointestinal cancer, 68Ga-PSMA PET imaging has shown promise in detecting prostate cancer, especially in identifying small metastases and relapses. This suggests potential usefulness in other cancers, like gastrointestinal, where precise imaging is crucial. ^{1 2 3 4 5}

Is 68Ga-PSMA PET Imaging safe for use in humans?

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

How is 68Ga-PSMA PET imaging different from other treatments for gastrointestinal cancer?

68Ga-PSMA PET imaging is unique because it uses a special tracer to detect cancer cells, which is typically used for prostate cancer, but is now being explored for gastrointestinal cancer. This imaging technique can potentially identify cancer spread more accurately than traditional methods, offering a new way to manage and treat gastrointestinal cancer. ^{1 2 3 11 12}

What is the purpose of this trial?

Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects. The main goal of this study is to confirm that patients with upper GI cancer would be eligible for ERT (177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

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-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 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]

References

1. Switzerland 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. [2022]

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

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

3. 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]

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

Cyclotron vs generator-produced 68Ga PSMA: a single-institution, prospective clinical trial. [2023]

5. 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]

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

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

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

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. [2020]

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

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. [2021]

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 Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli? [2021]