Using PSMA imaging for gastrointestinal tumors
Official title: A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
Run by Wuerzburg University Hospital · NCT05547919 · Data updated 2026-11-12
This study is testing if a special type of imaging called PSMA-PET can help find and understand gastrointestinal tumors better in patients with gastroenteropancreatic neuroendocrine neoplasms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Würzburg, Bavaria) |
| Status | Recruiting |
| Started | October 1, 2022 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2026 |
| Registry record updated | September 29, 2025 |
| Trial ID | NCT05547919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with newly diagnosed GEP-NEN who have not yet started anti-tumor therapy.
✕Probably not a fit
Patients with curative settings, insufficient tumor tissue, or those with prostate carcinoma will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of PSMA-directed imaging and therapy for patients with gastrointestinal tumors, specifically gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN). It aims to determine the expression of PSMA in biopsy samples and assess the effectiveness of PSMA-PET imaging in identifying disease sites compared to conventional imaging methods. The study will also explore whether the PSMA PET signal can predict clinical outcomes for patients undergoing standard treatment. Patients will undergo 18F-PSMA PET/CT scans to gather necessary data.
Why it matters
Potential benefit: If successful, this approach could enhance the diagnostic accuracy and treatment outcomes for patients with gastrointestinal cancers.
How similar studies have gone: While the use of PSMA in prostate cancer is well-established, its application in gastrointestinal tumors is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy * Available tissue specimen to conduct PSMA expression profiling * Male/female, above 18 years old * Patients must provide written informed consent * Patients must be willing to comply with study procedures and available for follow-up examinations Exclusion Criteria: * Curative setting * Not sufficient tumor tissue available * Male Patients: No prostate carcinoma * Other malignant neoplasms in patient's history * Pregnancy or Breastfeeding * Contraindications for PET/CT
Where it's running
-
University Hospital Wuerzburg
Würzburg, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Alexander M Weich, MD
- Email: weich_A@ukw.de
- Phone: +4993120140201
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Frailty before GI cancer surgery: does frailty predict post-op outcomes in older adults?
This study tests whether frailty measured before surgery can predict complications and recovery in patients 60 and older undergoing elective gastrointestinal cancer surgery.
-
Biological Collection to Help Create Models for Digestive Cancers and IBD
Researchers are gathering tissue and biological samples from patients with inflammatory bowel disease or digestive cancers to build personalized models and test new therapies.
-
Blood extracellular vesicles to detect chemotherapy-related nerve damage.
We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.
-
High-precision detection of leftover cancer using a liquid-biopsy platform (SHERLOCK)
This project will test whether sensitive blood and other fluid tests for circulating tumor DNA can find leftover cancer (minimal residual disease) in adults treated with curative intent for breast, lung, melanoma, gynecologic, or genitourinary cancers.
-
Dabrafenib and trametinib for rare cancers with BRAF V600 mutations
This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.
-
XH001 with neoantigen vaccine–primed tumor-specific T cells for advanced gastrointestinal cancer
This trial tests whether combining XH001 injections with T cells activated by a tumor neoantigen vaccine is safe and can shrink tumors or extend life in adults with advanced gastrointestinal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.