68Ga-PSMA PET Imaging of Upper Metastatic Gastric Cancers to Determine Eligibility to Endoradiotherapy

NCT05214820 | Active Not Recruiting Phase 2

• 1 other identifier: 2022-4378
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Upper Digestive Tract Cancer

Keywords

Imaging; 68Ga-PSMA; Dosimetry; Positron emission tomography (PET)

Outcome Measures

Primary Outcomes (1)

• Tumor uptake of 68Ga-PSMA

  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)

  At 1 hour post-injection acquisition

Secondary Outcomes (4)

• Tumor heterogeneity

  At 1 hour post-injection acquisition

• Tumor lesions that do not accumulate 68Ga-PSMA

  At 1 hour post-injection acquisition

• Effective half-life of 68Ga-PSMA

  At 30 minutes, 60 minutes and, 120 minutes post-injection

• Radiation dose (mGy)

  At 30 minutes, 60 minutes and120 minutes post-injection

Study Arms (1)

Single arm with 68Ga-PSMA

EXPERIMENTAL

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

Biological: Radiopharmaceutical 68Ga-PSMA

Interventions

Radiopharmaceutical 68Ga-PSMA BIOLOGICAL

Injection of 68Ga-PSMA followed by 3 PET/CT acquisitions

Single arm with 68Ga-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to provide free and informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead

Study Sites (1)

CIUSSS de l'Estrie- CHUS Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective pilot study

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 31, 2022
• Study Start: January 17, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)