NCT01075399

Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors

A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Lung Cancer
• Liver Cancer
• Rectal Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	[F 18]HX4	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

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-05-01
• Completion: 2012-02-01
• First posted: 2010-02-25
• Last updated: 2013-08-30
• Results posted: 2013-08-30