PSMA in Gastroenterologic Tumors (GIPSMA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWuerzburg University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Curative setting

Not sufficient tumor tissue available

Male Patients: No prostate carcinoma

Other malignant neoplasms in patient's history

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-PSMA PET/CT

    Radiation

    Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Gastroenterologic tumors histologically positive for PSMAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

True positive rate per patient specimen

The probability of GET is given when immunhistochemistry test is positive.

Time frame
24 months
2

True positive rate per patient

The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.

Time frame
24 months
3

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.

Time frame
24 months

Secondary outcomes

1

Ex-vivo PSMA expression

Expression of PSMA per specimen at immunhistochemistry.

Time frame
24 months
2

PSMA uptake on 18F-PSMA-1007 PET

Quantified uptake of PSMA per tumor lesion basis.

Time frame
24 months

Other outcomes

Sponsors and contacts

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