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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

Studienbeginn:
Oktober 2022

Letztes Update:
13.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Neuroendocrine Tumors

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Wuerzburg University Hospital

Collaborator:
-

Kontakt

Rudolf A Werner, MD
Kontakt:
Phone: +4993120135001
E-Mail: werner_r1@ukw.de» Kontaktdaten anzeigen

Alexander M Weich, MD
Kontakt:
Phone: +4993120140201
E-Mail: weich_a@ukw.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Wuerzburg
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Alexander M Weich, MD
Phone: +4993120140201
E-Mail: weich_a@ukw.de

Rudolf A Werner, MD
Phone: +4993120135001
E-Mail: werner_r1@ukw.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. True positive rate per patient specimen (Time Frame - 24 months):
The probability of GEP-NEN is given when immunhistochemistry test is positive.

2. True positive rate per patient (Time Frame - 24 months):
The probability of GEP-NEN is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.

3. 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 GEP-NEN to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.

Secondary outcome:

1. Ex-vivo PSMA expression (Time Frame - 24 months):
Expression of PSMA per specimen at immunhistochemistry.

2. PSMA uptake on 18F-PSMA-1007 PET (Time Frame - 24 months):
Quantified uptake of PSMA per tumor lesion basis.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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