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Sequential FDG-PET and miRNA as Biomarkers of Preoperative Treatment Strategy in LA Oesophago-Gastric Cancer

NCT07791329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-08-27

No results posted yet for this study

Summary

GastroPET is a prospective, multicenter, non-randomized interventional study evaluating sequential FDG-PET as an early biomarker to guide preoperative treatment in patients with locally advanced resectable oesophago-gastric adenocarcinoma. All patients receive an initial cycle of standard preoperative chemotherapy followed by a second FDG-PET scan. Based on the change in tumor FDG uptake, patients are classified as metabolic responders or non-responders. Metabolic responders continue preoperative chemotherapy, whereas metabolic non-responders switch to preoperative chemoradiotherapy. The study evaluates surgical and long-term outcomes of this response-adapted treatment strategy. Exploratory objectives include the evaluation of tissue and circulating miRNA and immune biomarkers in relation to metabolic response and treatment outcomes.

Conditions

  • Adenocarcinoma - Gastroesophageal Junction (GEJ)
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

DIAGNOSTIC_TEST

FDG-PET

FDG-PET scans will be performed before (baseline) and after 14 days of standard neoadjuvant treatment in specialized PET centers (MOÚ Brno, VFN Praha, FN Olomouc) according to the standard operation procedure and in accordance with the EANM guidelines. Data and records of the FDG-PET scans will be sent for central reading to PET Center MOÚ. Tracer uptake will be assessed semiquantitatively (standardized uptake values (SUV) using a circular region of interest (ROI) (diameter, 1.5 cm) with the TrueD software (Siemens Medical Solutions)). The percentage change in SUV will be calculated as ΔSUV = 100 × (SUVbaseline - SUVfollow-up)/SUVbaseline and used to classify patients as metabolic responders or non-responders and guide subsequent preoperative treatment.

Sponsors & Collaborators

  • University Hospital Olomouc

    collaborator OTHER

  • General University Hospital, Prague

    collaborator OTHER

  • Masaryk University

    collaborator OTHER

  • Masaryk Memorial Cancer Institute

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-10-01
Completion
2024-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791329 on ClinicalTrials.gov