Imaging for determining eligibility for endoradiotherapy in upper metastatic gastric cancers
Clinical Assessment of the Therapeutic Potential of 177Lu-PSMA Endoradiotherapy for the Treatment of Upper Metastatic Gastric Cancers Using 68Ga-PSMA PET-based Dosimetry
This study is testing if a special imaging scan can help find out if patients with certain upper gastrointestinal cancers can safely receive a new type of targeted radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT05214820 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the eligibility of patients with upper gastrointestinal cancers for endoradiotherapy (ERT) using 68Ga-PSMA PET imaging. It focuses on patients with adenocarcinoma of the esophagus, stomach, bile ducts, or pancreas, assessing the uptake of 68Ga-PSMA to determine if they can benefit from 177Lu-PSMA treatment. The study seeks to confirm whether these tumors consistently accumulate the imaging agent, which is crucial for the potential efficacy of ERT. By targeting tumor cells specifically, this approach aims to minimize damage to healthy tissue while delivering effective radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with active adenocarcinoma of the upper digestive tract documented by recent imaging.
Not a fit: Patients with other active cancers or those in remission for less than three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with upper GI cancers that minimizes side effects compared to traditional therapies.
How similar studies have performed: While there are case reports indicating the potential of 68Ga-PSMA in upper GI cancers, this study represents a novel approach as there are no prior prospective studies confirming these findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older * Active cancer of the type adenocarcinoma (of the esophagus, of the stomach, of the bile ducts, or of the pancreas) documented by a CT scan performed within the last 8 weeks at the time of recruitment. * An active cancer is defined as at least one lesion identified as stable or progressive neoplastic on CT imaging. * A lesion treated with local therapy (e.g., external radiotherapy, cryoablation, radiofrequency ablation, resection) is not counted for inclusion criteria if this is done between the CT scan and the 68Ga-PSMA PET imaging. A lesion treated prior to the last CT scan may be considered eligible if progression is documented at the last CT scan. * Able to provide free and informed consent. * Feasibility to perform 68Ga-PSMA PET within 2 months of the CT scan that was used for inclusion. Exclusion Criteria: * Other active cancer (non-metastatic non-melanoma skin cancer excluded). Cancer in remission for at least 3 years will not be considered active. * ECOG \> 3. * Pregnant woman. * Unable to follow study rules.
Where this trial is running
Sherbrooke, Quebec
- CIUSSS de l'Estrie- CHUS Hospital — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Amélie Tétu, MSc
- Email: amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
- Phone: 819 346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.