Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors (HX4-200)
This study has been completed.
Sponsor:
Siemens Molecular Imaging
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT01075399
First received: February 23, 2010
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Lung Cancer Liver Cancer Rectal Cancer Cervical Cancer |
Drug: [F 18]HX4 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors |
Resource links provided by NLM:
Further study details as provided by Siemens Molecular Imaging:
Primary Outcome Measures:
- To evaluate two sequential pre-treatment [F 18]HX4 PET scans (recommended to be within 48 hours of each other) in order to assess reproducibility and reliability of [F 18]HX4 PET imaging for measuring hypoxia in tumors [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: No ]
- To compare [F 18]HX4 PET/CT imaging with tissue immunohistochemistry staining using specific antibodies for HIF1alpha and /or CA-IX in order to assess the presence of hypoxia in tumor [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To collect vital signs, ECG, routine laboratory data and adverse events before the first pre-treatment [F 18]HX4 PET and after the second pre-treatment administration of [F 18]HX4 [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: Yes ]
- To establish a threshold value of tumor/background (T/B) ratio for [F 18]HX4 PET/CT imaging of hypoxic tissue [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: No ]
- To examine the standard uptake values (SUV) and T/B changes of [F 18]HX4 PET/CT imaging before treatment and after mid-treatment for patients that have one or more tumors with a T/B ratio ≥ 1.3 on both pre-treatment [F 18]HX4 PET/CT imaging scans [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: No ]
- To gain clinical experience and information to guide the design of a future, pivotal Phase II trial(s) [ Time Frame: (3) or (4) visits over a period of approximately 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: [F 18]HX4 |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Siemens Molecular Imaging |
| ClinicalTrials.gov Identifier: | NCT01075399 History of Changes |
| Other Study ID Numbers: | HX4-200 |
| Study First Received: | February 23, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Siemens Molecular Imaging:
|
[F 18]HX4 HX4 Hypoxia Head/Neck Cancer Lung Cancer |
Liver Cancer Rectal Cancer Cervical Cancer HIF1 alpha CAIX |
Additional relevant MeSH terms:
|
Rectal Neoplasms Uterine Cervical Neoplasms Head and Neck Neoplasms Liver Neoplasms Lung Neoplasms Anoxia Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Liver Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013