Head and Neck CancerPhase 2/3NCT00894101
Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
A Phase 2/3 study testing [F-18] FLT in people with Head and Neck Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- [F-18] FLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2010
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient provides written Informed Consent and is willing to comply with protocol requirements
- Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- Patient has a diagnosis of one of the following malignancies (TNM Staging System):
- Lung cancer (T3 grade up, node positive, but no metastatic disease)
- Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
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- Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
- Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
- As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18] FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
- Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
- Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
- Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale
Who cannot join
- Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
- by surgical history (eg, tubal ligation or hysterectomy),
- by patient's history of being post menopausal with a minimum 1 year without menses.
- Patient is undergoing treatment with palliative intent
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- Patient has received an investigational compound and/or medical device within 14 days before admission into this study
- Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
- Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiology, UCI Medical Center
Orange, California, 92868
About this study
Official title: A Phase II/III, Open Label, Non-Randomized, Multi-Center Study of Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
The purpose of this study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator.
- Conditions
- Head and Neck Cancer
- Being tested
- [F-18] FLT
- 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] FLTDrug
10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| [F-18] FLT and FDG | Experimental | Not described Receives: Drug: [F-18] FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: The main sponsor of this multi-center trial has submitted this protocol. A single participating site should not register this study.
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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894101
- Sponsor's protocol ID
- HS# 2009-6857
- Status last verified
- Jul 2018
- First submitted
- 4 May 2009
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Open Label, Non-Randomized, Multi-Center Study of Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
- ClinicalTrials.gov ID
- NCT00894101
- Acronym / sponsor ID
- HS# 2009-6857
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The main sponsor of this multi-center trial has submitted this protocol. A single participating site should not register this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 6 May 2009 (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 study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F-18] FLT and FDG | Experimental | Drug: [F-18] FLT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient provides written Informed Consent and is willing to comply with protocol requirements
- Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- Patient has a diagnosis of one of the following malignancies (TNM Staging System):
- Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
Key exclusion criteria (9 listed)
- Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:
- Patient is undergoing treatment with palliative intent
- Patient has received an investigational compound and/or medical device within 14 days before admission into this study
- Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
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] FLT10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging. | Drug | [F-18] FLT and FDG |
Primary outcome
The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG.
Time frame: 1 year
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 20 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing [F-18] FLT in people with Head and Neck Cancer, run by University of California, Irvine 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 12 inclusion and 9 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 20 Jul 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG. (time frame: 1 year). 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 20 Jul 2018.