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

NCT01075399 | Completed Phase 2 Results

• 1 other identifier: HX4-200
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors

  Primary tumor uptake of \[F 18\]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.

  Time between 1st and 2nd scan was 1 to 6 days

Study Arms (1)

[F 18]HX4

EXPERIMENTAL

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

Drug: [F 18]HX4

Interventions

[F 18]HX4 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

Also known as: [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

[F 18]HX4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Liver Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Hypoxia

Interventions

3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Edward M. Aten, MD, President
• Organization: Certus International, Inc.

eaten@certusintl.com

603.627.1212

Study Officials

• Jacqueline Brunetti, MD

  Holy Name Hospital

  PRINCIPAL INVESTIGATOR

• Orhan Nalcioglu, PhD

  University of California Irvine Medical Center, Orange, CA

  PRINCIPAL INVESTIGATOR

• Alan Waxman, MD

  Cedars-Sinai Medical Center, Los Angeles, CA

  PRINCIPAL INVESTIGATOR

• Kyung-Han Lee, MD

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

  PRINCIPAL INVESTIGATOR

• Dae-Hyuk Moon, MD

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

  PRINCIPAL INVESTIGATOR

• Scott Dessain, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Rathan Subamaniam, MD

  Boston Medical Center, Boston, MA

  PRINCIPAL INVESTIGATOR

• Shyam Srinivas, MD, PhD

  Cleveland Clinic, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Nasrin Ghesani, MD

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

  PRINCIPAL INVESTIGATOR

• John M Buatti, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-07