CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
[F 18]HX4drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01075399
NCT01075399Phase 2Completed
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A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors

Siemens Molecular Imaging·interventional·Posted Feb 25, 2010·Updated Aug 30, 2013

In Brief

A Phase 2 clinical trial evaluating [F 18]HX4 for Head and Neck Cancer and 4 related conditions. Completed, enrolled 50 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Lung Cancer, Liver Cancer, Rectal Cancer, Cervical Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.4 years ago

Interventions

[F 18]HX4drug

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