Head and Neck CancerPhase 1/2NCT01506427
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
A Phase 1/2 study testing [F-18] HX4 in people with Head and Neck Cancer, run by Siemens Molecular Imaging at 1 site in United States.
Trial summary
The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- [F-18] HX4
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, 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 inform consent Patient is willing and able to comply with protocol procedures.
- Patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx.
- Patient is scheduled to have or already has had a clinical [F-18]FDG PET/CT scan prior (recommended to be within 14 days prior) to the [F-18]HX4 PET/CT scan.
- Patient has a primary tumor ≥ 2.0 cm in longest axis measured by CT or MR; or lymph node ≥ 2.0 cm in shortest axis measured by CT or MR if primary tumor < 2 cm on CT or MR; CT may be part of required [F-18]FDG PET/CT scan or a separate pre-surgery CT scan.
- Patient is scheduled to undergo complete tumor resection within 7 days for his/her cancer care after the [F-18]HX4 PET/CT scan is performed.
- Patient has not had nor will have neoadjuvant treatment, including radiation and chemotherapy, prior to patient's planned tumor resection.
Who cannot join
- Female patient is pregnant or nursing.
- Patient is not capable of remaining still for duration of imaging procedure (~ 4 hours).
- Patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period.
- Patient has chronic renal function failure or is on renal dialysis
- Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Medical Center
Iowa City, Iowa, 52242
About this study
Official title: A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients
The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.
Read the detailed description
Each consented patient will have a single administration of [F-18]HX4 and will immediately undergo one list mode PET/CT imaging session lasting 60 minutes followed by three additional list mode PET/CT acquisitions from 90 to 110 minutes, 150 to 170 minutes and 220 to 250 minutes after administration. The start times of the last three image acquisitions are permitted to be within ± 5 minutes. Venous blood samples will be collected throughout the initial scan sequence and at the time of each subsequent acquisition for calibration and metabolite-correction of the image-derived input function. On the day of administration (Visit 2) blood for clinical safety evaluations will be drawn pre- and post-dosing after all imaging is complete.
The pre-surgery [F-18]FDG PET/CT clinical scan performed prior to the [F-18]HX4 procedure, and the surgery at Visit 3 are standard of care for the consented patients.
- Conditions
- Head and Neck Cancer
- Being tested
- [F-18] HX4
- Keywords
- Newly Diagnosed, Head and Neck Cancer, PET Imaging
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18] HX4Radiation
A single dose of 10 mCi, injected intravenously.
| Study group | Role | What they receive |
|---|---|---|
| [F-18] HX4 | Experimental | Not described Receives: Radiation: [F-18] HX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial measures of T/B Ratios and other imaging parameters
Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.
Measured: Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out
Secondary outcomes (3)
Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements
Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements obtained from surgical tumor samples
Measured: Estimated analysis to occur 1 month after patient surgery
Kinetic Modeling Analysis
Kinetic parameters obtained from modeling time course of PET imaging data following [F-18]HX4 administration
Measured: Estimated to be 2 weeks after the Imaging Date (Visit 2)
Safety Assessments
Safety measurements including incidence of adverse events, and pre- and post-drug clinical laboratory measurements, vital signs and electrocardiograms
Measured: On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Buatti, MD, Principal investigator, University of Iowa Medical CenterEdward Aten, MD, Study director, President, Certus International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506427
- Sponsor's protocol ID
- HX4-201
- Status last verified
- Dec 2012
- First submitted
- 28 Dec 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01506427
- Acronym / sponsor ID
- HX4-201
- Conditions
- Head and Neck Cancer
- Keywords
- Newly Diagnosed, Head and Neck Cancer, PET Imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.
Detailed description
Each consented patient will have a single administration of [F-18]HX4 and will immediately undergo one list mode PET/CT imaging session lasting 60 minutes followed by three additional list mode PET/CT acquisitions from 90 to 110 minutes, 150 to 170 minutes and 220 to 250 minutes after administration. The start times of the last three image acquisitions are permitted to be within ± 5 minutes. Venous blood samples will be collected throughout the initial scan sequence and at the time of each subsequent acquisition for calibration and metabolite-correction of the image-derived input function. On the day of administration (Visit 2) blood for clinical safety evaluations will be drawn pre- and post-dosing after all imaging is complete.
The pre-surgery [F-18]FDG PET/CT clinical scan performed prior to the [F-18]HX4 procedure, and the surgery at Visit 3 are standard of care for the consented patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F-18] HX4 | Experimental | Radiation: [F-18] HX4 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is >18 years and male or female of any race / ethnicity.
- Patient or patient's legally acceptable representative provides written inform consent Patient is willing and able to comply with protocol procedures.
- Patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx.
- Patient is scheduled to have or already has had a clinical [F-18]FDG PET/CT scan prior (recommended to be within 14 days prior) to the [F-18]HX4 PET/CT scan.
- Patient has a primary tumor ≥ 2.0 cm in longest axis measured by CT or MR; or lymph node ≥ 2.0 cm in shortest axis measured by CT or MR if primary tumor < 2 cm on CT or MR; CT may be part of required [F-18]FDG PET/CT scan or a separate pre-surgery CT scan.
Key exclusion criteria (5 listed)
- Female patient is pregnant or nursing.
- Patient is not capable of remaining still for duration of imaging procedure (~ 4 hours).
- Patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period.
- Patient has chronic renal function failure or is on renal dialysis
- 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] HX4A single dose of 10 mCi, injected intravenously. | Radiation | [F-18] HX4 |
Primary outcome
Serial measures of T/B Ratios and other imaging parameters
Time frame: Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out
Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.
3 secondary outcomes
Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements
Time frame: Estimated analysis to occur 1 month after patient surgery
Kinetic Modeling Analysis
Time frame: Estimated to be 2 weeks after the Imaging Date (Visit 2)
Safety Assessments
Time frame: On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
John Buatti, MD principal investigator
University of Iowa Medical Center
Edward Aten, MD study director
President, Certus International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [F-18] HX4 in people with Head and Neck Cancer, run by Siemens Molecular Imaging at 1 site in United States.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Serial measures of T/B Ratios and other imaging parameters (time frame: Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out). 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 17 Dec 2012.