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PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms) (GIPSMA)

Primary Purpose

Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
18F-PSMA PET/CT
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with newly diagnosed GIT/HCC 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

Sites / Locations

  • University Hospital WuerzburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastrointestinal tumors histologically positive for PSMA

Arm 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.

Outcomes

Primary Outcome Measures

True positive rate per patient specimen
The probability of GEP-NEN is given when immunhistochemistry test is positive.
True positive rate per patient
The probability of GEP-NEN is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
Number of patients with identified tumor lesion sites
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GEP-NEN to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.

Secondary Outcome Measures

Ex-vivo PSMA expression
Expression of PSMA per specimen at immunhistochemistry.
PSMA uptake on 18F-PSMA-1007 PET
Quantified uptake of PSMA per tumor lesion basis.

Full Information

First Posted
August 26, 2022
Last Updated
September 11, 2023
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05547919
Brief Title
PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms)
Acronym
GIPSMA
Official Title
A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastrointestinal Tumors (Focusing on Neuroendocrine Neoplasms)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. Gastrointestinal tumors (GIT), including gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) 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 GEP-NEN 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastrointestinal tumors histologically positive for PSMA
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
18F-PSMA PET/CT
Intervention Description
Patients with metastasized gastrointestinal tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.
Primary Outcome Measure Information:
Title
True positive rate per patient specimen
Description
The probability of GEP-NEN is given when immunhistochemistry test is positive.
Time Frame
24 months
Title
True positive rate per patient
Description
The probability of GEP-NEN is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
Time Frame
24 months
Title
Number of patients with identified tumor lesion sites
Description
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GEP-NEN to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Ex-vivo PSMA expression
Description
Expression of PSMA per specimen at immunhistochemistry.
Time Frame
24 months
Title
PSMA uptake on 18F-PSMA-1007 PET
Description
Quantified uptake of PSMA per tumor lesion basis.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly diagnosed GEP-NEN 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf A Werner, MD
Phone
+4993120135001
Email
werner_r1@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander M Weich, MD
Phone
+4993120140201
Email
weich_a@ukw.de
Facility Information:
Facility Name
University Hospital Wuerzburg
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander M Weich, MD
Phone
+4993120140201
Email
weich_a@ukw.de
First Name & Middle Initial & Last Name & Degree
Rudolf A Werner, MD
Phone
+4993120135001
Email
werner_r1@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

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PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms)

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