Clinical trial · Interventional
PSMA in Gastroenterologic Tumors (GIPSMA)
A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
- 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)
The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular Carcinoma, gastroenteropancreatic neuroendocrine neoplasms also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GET patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.
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 |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA PET/CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gastroenterologic tumors histologically positive for PSMA
- description
- Tumor biopsy at baseline to establish diagnosis and to identify PSMA expression in an ex-vivo setting. Patients with ex-vivo PSMA expression receive a multimodal imaging approach: This includes a PSMA-targeted PET/CT (18F-PSMA) at baseline and conventional imaging.
- interventionNames
- Radiation: 18F-PSMA PET/CT
Primary outcomes (3)
- measure
- True positive rate per patient specimen
- timeFrame
- 24 months
- description
- The probability of GET is given when immunhistochemistry test is positive.
- measure
- True positive rate per patient
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMichalski K, Reiter FP, Kosmala A, Hartrampf PE, Seifert S, Kalogirou C, Kircher S, Bley TA, Geier A, Meining A, Buck AK, Werner RA, Weich A. Diagnostic Performance of [18F]PSMA-1007 PET/CT on Proven PSMA-Positive Hepatocellular Carcinoma: A Prospective Clinical Study. J Nucl Med. 2026 Jan 2;67(1):43-48. doi: 10.2967/jnumed.125.270755. PMID 41198240