Clinical trial NCT01075399
Conditions: Head and Neck Cancer Lung Cancer Liver Cancer Rectal Cancer Cervical Cancer
Keywords: [F 18]HX4 HX4 Hypoxia Head/Neck Cancer Lung Cancer Liver Cancer Rectal Cancer Cervical Cancer HIF1 alpha CAIX
Sponsor: Siemens Molecular Imaging
Start date: 2010-02-01; Completion date: 2012-02-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II study is designed as a test and retest study to investigate \[F 18\]HX4 as a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to establish a threshold for \[F 18\]HX4 uptake in the tumor. The study will evaluate the relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and tumor uptake of \[F 18\]HX4 by PET imaging.

Detailed description:
A Pilot Phase II Study

The primary objectives for this study are:

* To test the reproducibility of \[F-18\] HX-4 uptake in tumors by imaging the same patient on sequential days in a test-retest protocol
* To test and confirm the relationship between hypoxia in tumors measured by hypoxia related biomarkers (HIF1α and CA-IX) with immunohistochemistry (IHC) and regional \[F-18 HX-4\] uptake in tumors with PET/CT.

The secondary objectives for this study are:

* To continue safety evaluation by the collection of safety data from all patients
* To establish the threshold for hypoxia uptake in \[F- 18\]HX4 PET imaging
* To collect data to test \[F-18\]HX4 PET imaging as a predictor of response in a subgroup of patients receiving treatment
* To gain experience with \[F-18\]HX4 PET/CT in order to improve the study design to conduct future studies

Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study

Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, two or three sets of \[F-18\]HX4 dosing and imaging scans including two pretreatment, and one mid-treatment if \[F-18\]HX4 tumor/background ratio ≥ 1.3 from pre-treatment scans, one pre-treatment \[F-18\]FDG, one mid-treatment if \[F- 18\]HX4 tumor/background ratio ≥1.3 from pre-treatment scans, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment

Patients: Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy. This allows for approximately 30 evaluable patients to complete this study at approximately six sites.

Arms: arm 1: \[F18\]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush.
Interventions: intervention 1: [F 18]HX4
Intervention descriptions: intervention 1: Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with \[F 18\]HX4

Protocol documents: