68Ga-PSMA PET Imaging for Gastrointestinal Cancer
(ERD2021 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Disqualifiers: Other active cancer, ECOG > 3, pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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).
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.
12345Is 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.
678910How 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.
1231112Eligibility 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.
+3 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single arm with 68Ga-PSMAExperimental Treatment1 Intervention
All participants will undergo a PET scan with 68Ga-PSMA
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CIUSSS de l'Estrie- CHUS HospitalSherbrooke, Canada
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Who Is Running the Clinical Trial?
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
References
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]Label="CONTEXT">Positron emission tomography (PET) of 68Ga-labelled prostate-specific membrane antigen (68Ga-PSMA) is an emerging imaging modality introduced to assess the burden of prostate cancer, typically in biochemically recurrent or advanced disease. 68Ga-PSMA PET provides the ability to selectively identify and localize metastatic prostate cancer cells and subsequently change patient management. Owing to its limited history, robust sensitivity and specificity data are not available for 68Ga-PSMA PET-positive scans.
Gallium-68 Prostate-Specific Membrane Antigen PET Imaging. [2018]The role of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) PET imaging is evolving and finding its place in the imaging armamentarium for prostate cancer (PCa). Despite the progress of conventional imaging strategies, significant limitations remain, including identification of small-volume disease and assessment of bone. Clinical studies have demonstrated that 68Ga-PSMA is a promising tracer for detection of PCa metastases, even in patients with low prostate-specific antigen. To provide an accurate interpretation of 68Ga-PSMA PET/computed tomography, nuclear medicine specialists and radiologists should be familiar with physiologic 68Ga-PSMA uptake, common variants, patterns of locoregional and distant spread of PCa, and inherent pitfalls.
68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. [2021]Label="RATIONALE AND OBJECTIVES"> 68Ga-prostate-specific membrane antigen-11 (68Ga-PSMA-11) is a recently developed positron emission tomography (PET) tracer that can detect prostate cancer (PC) relapses and metastases with high contrast resolution. The aim of this study was to assess the detection efficacy and diagnostic accuracy of 68Ga-PSMA PET/CT image in patients with rising prostatic-specific antigen (PSA) after treatment of PC.
Cyclotron vs generator-produced 68Ga PSMA: a single-institution, prospective clinical trial. [2023]The clinical utility of gallium 68 (68Ga)-PSMA PET for the diagnosis and management of prostate cancer is driven in part by radioisotope availability and production costs. This study evaluates the equivalence between the two manufacturing processes for 68Ga-PSMA: 68Ga-PSMA-cyclotron (from a solid target) and 68Ga-PSMA-generator. A prospective, single-arm, single-institution non-randomized study was conducted where 16 patients with prostate adenocarcinoma underwent PET/CTs consecutively within 12 to 48 hours with each type of manufactured 68Ga-PSMA between December 2020 and June 2021. The intraclass correlation coefficients suggested acceptable reliability in all lesion parameters (ICC > 0.70). Bland-Altman analysis demonstrated acceptable bias levels for all lesion parameters. Thereby 68Ga-cyclotron (solid target) and 68Ga-generator production methods tagged to the same PSMA ligand resulted in scans which were deemed to be equivalent in detecting PSMA+ lesions in our study. As cyclotron-produced, solid- target 68Ga can be made in large (Ci) quantities, it is a promising tool for future application in 68Ga-PSMA PET scans with the potential to decrease radiotracer production costs and increase isotope availability.
68Ga-PSMA-11 PET/CT in recurrent prostate cancer: efficacy in different clinical stages of PSA failure after radical therapy. [2021]Label="OBJECTIVES">The primary objective was the evaluation of Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-11 positron emission tomography/computed tomography (PET/CT) detection rate, for identifying the site of prostate cancer (PCa) relapse (local vs systemic), stratifying the population according to different clinical stages of biochemical recurrence (BCR). Secondary aims were: 1) to evaluate the association of clinical/pathologic features and 68Ga-PSMA-11 PET/CT detection rate, 2) to compare 68Ga-PSMA-11 PET/CT with other imaging procedures, and 3) to evaluate the positive predictive value (PPV) in a per-patient analysis.
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]Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of 68Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of 68Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of 68Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to 68Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Conclusion: 68Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of 68Ga-THP PSMA in patients with prostate cancer.
[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. [2020]Imaging of the prostate-specific membrane antigen (PSMA) has become an important tool for managing patients with recurrent prostate cancer, and one of the most frequently employed radiopharmaceuticals is [68Ga]Ga-PSMA-11. Herein, we summarize the preclinical development and the clinical applications of [68Ga]Ga-PSMA-11 and present side-by-side comparisons with other radiopharmaceuticals or imaging modalities, in order to assist imagers and clinicians in recommending, performing, and interpreting the results of [68Ga]Ga-PSMA-11 PET scans in patients with prostate cancer.
Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND"> 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC ([68Ga]PSMA-11) has been increasingly used to image prostate cancer using positron emission tomography (PET)/computed tomography (CT) both during diagnosis and treatment planning. It has been shown to be of clinical value for patients both in the primary and secondary stages of prostate cancer. The aim of this study was to determine the effective dose and organ doses from injection of [68Ga]PSMA-11 in a cohort of low-risk prostate cancer patients.
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]The aim of this study was to evaluate the clinical safety profile of the Ga-PSMA-11 ligand for PET/CT imaging in prospective clinical trials.
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]68Ga-labeled urea-based inhibitors of the prostate-specific membrane antigen (PSMA), such as 68Ga-labeled N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid (HBED)-PSMA-11, are promising small molecules for targeting prostate cancer. A new radiopharmaceutical, 68Ga-labeled tris(hydroxypyridinone) (THP)-PSMA, has a simplified design for single-step kit-based radiolabeling. It features the THP ligand, which forms complexes with 68Ga3+ rapidly at a low concentration, at room temperature, and over a wide pH range, enabling direct elution from a 68Ge/68Ga generator into a lyophilized radiopharmaceutical kit in 1 step without manipulation. The aim of this phase 1 study was to assess the safety and biodistribution of 68Ga-THP-PSMA. Methods: Cohort A comprised 8 patients who had proven prostate cancer and were scheduled to undergo prostatectomy; they had Gleason scores of 7-10 and a mean prostate-specific antigen level of 7.8 μg/L (range, 5.4-10.6 μg/L). They underwent PET/CT after the administration of 68Ga-THP-PSMA. All patients proceeded to prostatectomy (7 with pelvic nodal dissection). Dosimetry from multi-time-point PET imaging was performed with OLINDA/EXM. Cohort B comprised 6 patients who had positive 68Ga-HBED-PSMA-11 PET/CT scanning results and underwent comparative 68Ga-THP-PSMA scanning. All patients were monitored for adverse events. Results: No adverse events occurred. In cohort A, 6 of 8 patients had focal uptake in the prostate (at 2 h: average SUVmax, 5.1; range, 2.4-9.2) and correlative 3+ staining of prostatectomy specimens on PSMA immunohistochemistry. The 2 68Ga-THP-PSMA scans with negative results had only 1+/2+ staining. The mean effective dose was 2.07E-02 mSv/MBq. In cohort B, 68Ga-THP-PSMA had lower physiologic background uptake than 68Ga-HBED-PSMA-11 (in the parotid glands, the mean SUVmax for 68Ga-THP-PSMA was 3.6 [compared with 19.2 for 68Ga-HBED-PSMA-11]; the respective corresponding values in the liver were 2.7 and 6.3, and those in the spleen were 2.7 and 10.5; P < 0.001 for all). In 5 of 6 patients, there was concordance in the number of metastases identified with 68Ga-HBED-PSMA-11 and 68Ga-THP-PSMA. Thirteen of 15 nodal abnormalities were subcentimeter. In 22 malignant lesions, the tumor-to-liver contrast with 68Ga-THP-PSMA was similar to that with 68Ga-HBED-PSMA (4.7 and 5.4, respectively; P = 0.15), despite a higher SUVmax for 68Ga-HBED-PSMA than for 68Ga-THP-PSMA (30.3 and 10.7, respectively; P < 0.01). Conclusion:68Ga-THP-PSMA is safe and has a favorable biodistribution for clinical imaging. Observed focal uptake in the prostate was localized to PSMA-expressing malignant tissue on histopathology. Metastatic PSMA-avid foci were also visualized with 68Ga-THP-PSMA PET. Single-step production from a Good Manufacturing Practice cold kit may enable rapid adoption.
68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? [2021]Ever since the introduction of 68Ga-prostate-specific membrane antigen 11 positron-emission tomography/computed tomography (68Ga-PSMA-11 PET/CT) a few years ago, it has rapidly achieved great success in the field of prostate cancer imaging. A large number of studies have been published to date, indicating a high potential of 68Ga-PSMA-11 PET/CT in the work-up of prostate cancer patients, including primary diagnosis, staging and biochemical recurrence. The aim of this review is to present the most important data on this novel, highly promising imaging technique, and to formulate recommendations for possible applications of 68Ga-PSMA-11 PET/CT in clinical routine.
68Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli? [2021]Label="PURPOSE"> 68Ga ligands targeting prostate-specific membrane antigen (PSMA) are rapidly emerging as a significant step forward in the management of prostate cancer. PSMA is a type II transmembrane protein with high expression in prostate carcinoma cells. We prospectively evaluated the use of 68Ga-PSMA positron emission tomography/computed tomography (PET/CT) in patients with prostate cancer and compared the results to those for technetium-99m (99mTc)-10-metacyloyloxydecyl dihydrogen phosphate (MDP) bone scintigraphy (BS).