Clinical trial · Interventional
68Ga-PSMA PET Imaging of Upper Metastatic Gastric Cancers to Determine Eligibility to Endoradiotherapy
Clinical Assessment of the Therapeutic Potential of 177Lu-PSMA Endoradiotherapy for the Treatment of Upper Metastatic Gastric Cancers Using 68Ga-PSMA PET-based Dosimetry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Digestive Tract Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiopharmaceutical 68Ga-PSMA | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm with 68Ga-PSMA
- description
- All participants will undergo a PET scan with 68Ga-PSMA
- interventionNames
- Biological: Radiopharmaceutical 68Ga-PSMA
Primary outcomes (1)
- measure
- Tumor uptake of 68Ga-PSMA
- timeFrame
- At 1 hour post-injection acquisition
- description
- Proportion of participants with tumor uptake equal to or greater than 1.5 times the mean hepatic uptake (SUVmean) on 68Ga-PSMA PET according to the criteria suggested by the European Association of Nuclear Medicine (EANM)
Secondary outcomes (4)
- measure
- Tumor heterogeneity
- timeFrame
- At 1 hour post-injection acquisition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available