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

NCT ID: NCT01075399

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-02-29

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

[F 18]HX4

\[F18\]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush.

Group Type: EXPERIMENTAL

[F 18]HX4

Intervention Type: DRUG

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

Interventions

[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

Intervention Type: DRUG

Other Intervention Names

[F-18]HX4; 3-[18F]fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl); -1H-1,2,3-triazol-1-yl)-propan-1-ol

Eligibility Criteria

Inclusion Criteria

• Patient is >18 years and male or female of any race / ethnicity
• Patient or patient's legally acceptable representative provides written informed consent and is willing to comply with protocol procedures
• Patient must have histopathologically confirmed head/neck, lung, liver, rectal or cervical cancer with tumor size ≥ 3cm
• Patient has tumor tissue samples available before treatment for future immunohistochemistry biomarker tests (HIF1alpha and CA-IX)
• Patient is scheduled to have or already had a clinical [F 18]FDG PET/CT scan recommended to be within 14 days of the first pre-treatment [F 18]HX4 PET/CT scan and have no treatment intervention in between these two scans
• Patient is scheduled or is intended to be scheduled to receive chemotherapy, radiation or chemoradiotherapy treatment(s) after the pre-treatment [F 18]HX4 PET/CT and [F 18]FDG PET/CT scans for his/her cancer care
• Patient must have hepatic and renal functions as defined by laboratory results within the following ranges:

• Total bilirubin within 2 times institutional upper limit of normal
• AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limits of normal
• Serum creatinine ≤ 2.5 times institutional limit of normal
• BUN within 2 times institutional upper limit of normal

Exclusion Criteria

• Patient is not capable of complying with study procedures
• Female patient is pregnant or nursing

o Exclude the possibility of pregnancy by one of the following:

• Confirming in medical history that the patient is post-menopausal for a minimum of one year, or surgically sterile
• Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
• Confirming a negative urine dipstick test taken the morning of but before receiving [F 18]HX4
• Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Molecular Imaging

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline Brunetti, MD

Role: PRINCIPAL_INVESTIGATOR

Holy Name Hospital

Orhan Nalcioglu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California Irvine Medical Center, Orange, CA

Alan Waxman, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Los Angeles, CA

Kyung-Han Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Sungkyunkwan University School of Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Korea

Dae-Hyuk Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulsan College of Medicine, Asan Medical Center, Songpa-gu, Seoul, Korea

Scott Dessain, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lankenau Institute for Medical Research, Wynnewood, PA and Bryn Mawr Hospital Outpatient Imaging Center, Bryn Mawr, PA

Rathan Subamaniam, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Boston, MA

Shyam Srinivas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Cleveland, OH

Nasrin Ghesani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Dentistry of New Jersey, NJMS-UH/UMDNJ Cancer Center, and University Heights Advanced Imaging Center, Newark, NJ

John M Buatti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Hospitals and Clinics, Carver College of Medicine, and Holden Comprehensive Cancer Center,Iowa City, Iowa

Countries

United States

Other Identifiers

HX4-200

Identifier Type: -

Identifier Source: org_study_id