In vivo assessment of hypoxia in gastro-intestinal cancer using 18F-HX4-PET: an optimization and reproducibility study

Completed

• Conditions: cancer; 10017990

• Registration Number: NL-OMON37773
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Patients with biopsy proven invasive carcinoma of the esophagus, pancreas or rectum. In pancreatic cancer cytological proof or a high suspicion on CT imaging is allowed, too.
- Any tumor with a size * 1cm
- WHO-performance score 0-2
- Written informed consent

Exclusion Criteria

- Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
- Surgery, radiation and/or chemotherapy foreseen within the timeframe needed for two PET scans.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are the optimal time point for 18F-HX4-PET scanning and<br /><br>the reproducibility of hypoxia measured non-invasively in vivo with<br /><br>18F-HX4-PET.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are correlations of levels of hypoxia measured by<br /><br>18F-HX4-PET with endogenous hypoxia markers determined by immunohistochemistry<br /><br>(HIF1-alfa, CA9, PAI-1, VEGF) in pretreatment tumor biopsies or surgical<br /><br>specimens and with pathological response to treatment in surgical specimens<br /><br>after neo-adjuvant treatment. </p><br>