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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37773

Enrollment

Registered

2012-05-25

Start date

2012-05-25

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoints are the optimal time point for 18F-HX4-PET scanning and the reproducibility of hypoxia measured non-invasively in vivo with 18F-HX4-PET.	—

Secondary

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

Countries

Netherlands

Outcome results