Head and Neck CancerPhase 2HX4-200NCT01075399
Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors
A Phase 2 study testing [F 18]HX4 in people with Head and Neck Cancer and Lung Cancer, run by Siemens Molecular Imaging.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Liver Cancer
- What is being tested?
- [F 18]HX4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
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
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.
Read the 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
- Being tested
- [F 18]HX4
- Keywords
- [F 18]HX4, HX4, Hypoxia, Head/Neck Cancer, Lung Cancer, Liver Cancer, Rectal Cancer, Cervical Cancer, HIF1 alpha, CAIX
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Liver Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F 18]HX4Drug
Also called [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
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
| Study group | Role | What they receive |
|---|---|---|
| [F 18]HX4 | Experimental | [F18]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush. Receives: Drug: [F 18]HX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time between 1st and 2nd scan was 1 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Brunetti, MD, Principal investigator, Holy Name HospitalOrhan Nalcioglu, PhD, Principal investigator, University of California Irvine Medical Center, Orange, CAAlan Waxman, MD, Principal investigator, Cedars-Sinai Medical Center, Los Angeles, CAKyung-Han Lee, MD, Principal investigator, Sungkyunkwan University School of Medicine, Samsung Medical Center, Gangnam-gu, Seoul, KoreaDae-Hyuk Moon, MD, Principal investigator, University of Ulsan College of Medicine, Asan Medical Center, Songpa-gu, Seoul, KoreaScott Dessain, MD, PhD, Principal investigator, Lankenau Institute for Medical Research, Wynnewood, PA and Bryn Mawr Hospital Outpatient Imaging Center, Bryn Mawr, PARathan Subamaniam, MD, Principal investigator, Boston Medical Center, Boston, MAShyam Srinivas, MD, PhD, Principal investigator, Cleveland Clinic, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075399
- Sponsor's protocol ID
- HX4-200
- Acronym
- HX4-200
- Status last verified
- Jul 2013
- First submitted
- 23 Feb 2010
- Last updated
- 30 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01075399
- Acronym / sponsor ID
- HX4-200 / HX4-200
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 30 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F 18]HX4 | Experimental | Drug: [F 18]HX4[F18]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- Patient is not capable of complying with study procedures
- Female patient is pregnant or nursing
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F 18]HX4Also: [F-18]HX4, 3-[18F]fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl), -1H-1,2,3-triazol-1-yl)-propan-1-olApproximately 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 | Drug | [F 18]HX4 |
Primary outcome
Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors
Time frame: Time between 1st and 2nd scan was 1 to 6 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Brunetti, MD principal investigator
Holy Name Hospital
Orhan Nalcioglu, PhD principal investigator
University of California Irvine Medical Center, Orange, CA
Alan Waxman, MD principal investigator
Cedars-Sinai Medical Center, Los Angeles, CA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [F 18]HX4 in people with Head and Neck Cancer and Lung Cancer, run by Siemens Molecular Imaging.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors (time frame: Time between 1st and 2nd scan was 1 to 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.