Gastrointestinal CancerGIPSMANCT05547919
PSMA in Gastroenterologic Tumors (GIPSMA)
A study testing 18F-PSMA PET/CT in people with Gastrointestinal Cancer, run by Wuerzburg University Hospital at 1 site in Germany.
Trial 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. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- 18F-PSMA PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Wuerzburg
Würzburg, Bavaria, 97080
Alexander M Weich, MD, +4993120140201, weich_a@ukw.de
Rudolf A Werner, MD, +4993120135001, werner_r1@ukw.de
About this study
Official title: A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
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
- Gastrointestinal Cancer
- Being tested
- 18F-PSMA PET/CT
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA PET/CTRadiation
Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.
| Study group | Role | What they receive |
|---|---|---|
| Gastroenterologic tumors histologically positive for PSMA | Experimental | 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. Receives: Radiation: 18F-PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
True positive rate per patient specimen
The probability of GET is given when immunhistochemistry test is positive.
Measured: 24 months
True positive rate per patient
The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
Measured: 24 months
Number of patients with identified tumor lesion sites
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.
Measured: 24 months
Secondary outcomes (2)
Ex-vivo PSMA expression
Expression of PSMA per specimen at immunhistochemistry.
Measured: 24 months
PSMA uptake on 18F-PSMA-1007 PET
Quantified uptake of PSMA per tumor lesion basis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547919
- Sponsor's protocol ID
- GI-PSMA22
- Acronym
- GIPSMA
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michalski 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.
PubMed 41198240
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
- ClinicalTrials.gov ID
- NCT05547919
- Acronym / sponsor ID
- GIPSMA / GI-PSMA22
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroenterologic tumors histologically positive for PSMA | Experimental | Radiation: 18F-PSMA PET/CTTumor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Curative setting
- Not sufficient tumor tissue available
- Male Patients: No prostate carcinoma
- Other malignant neoplasms in patient's history
- Pregnancy or Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PSMA PET/CTPatients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging. | Radiation | Gastroenterologic tumors histologically positive for PSMA |
Primary outcome
True positive rate per patient specimen
Time frame: 24 months
The probability of GET is given when immunhistochemistry test is positive.
True positive rate per patient
Time frame: 24 months
The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
Number of patients with identified tumor lesion sites
Time frame: 24 months
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.
2 secondary outcomes
Ex-vivo PSMA expression
Time frame: 24 months
PSMA uptake on 18F-PSMA-1007 PET
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 41198240Michalski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-PSMA PET/CT in people with Gastrointestinal Cancer, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander M Weich, MD (+4993120140201, weich_A@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True positive rate per patient specimen (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.