Using PSMA imaging for gastrointestinal tumors
A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Würzburg, Bavaria) |
| Trial ID | NCT05547919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with newly diagnosed GEP-NEN who have not yet started anti-tumor therapy.
Not a fit: Patients with curative settings, insufficient tumor tissue, or those with prostate carcinoma will not benefit from this study.
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 performed: While the use of PSMA in prostate cancer is well-established, its application in gastrointestinal tumors is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Würzburg, Bavaria
- University Hospital Wuerzburg — Würzburg, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Alexander M Weich, MD
- Email: weich_A@ukw.de
- Phone: +4993120140201
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.