CNS Brain MetastasisNCT00585741
Pilot Study of 18F-FLT PET
A study testing Imaging with 18F-FLT PET in people with CNS Brain Metastasis and Head and Neck Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer
- What is being tested?
- Imaging with 18F-FLT PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2011
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to tolerate a PET/CT scan
- Age of 18 or older
- signed informed consent
- being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer
Who cannot join
- Prior XRT to site being studied
- severe claustrophobia or inability to tolerate PET/CT
- unable to provide written consent
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and clinis
Madison, Wisconsin, 53792
About this study
Official title: Pilot Study of 18F-FLT Pet Imaging in Cancer Patients
Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission
- Conditions
- CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer
- Being tested
- Imaging with 18F-FLT PET
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging with 18F-FLT PETProcedure or surgery
Imaging with 18F-FLT PET
Imaging with 18F-FLT PETProcedure or surgery
Imaging with 18F-FLT PET
Imaging with 18F-FLT PETProcedure or surgery
Imaging with 18F-FLT PET
Imaging with 18F-FLT PETProcedure or surgery
Imaging with 18F-FLT PET
Imaging with 18F-FLT PETProcedure or surgery
Imaging with 18F-FLT PET
| Study group | Role | What they receive |
|---|---|---|
| 2. Head and neck | Experimental | Imaging with 18F-FLT PET Receives: Procedure: Imaging with 18F-FLT PET |
| 3. Lung | Experimental | Imaging with 18F-FLT PET Receives: Procedure: Imaging with 18F-FLT PET |
| 4. prostate | Experimental | Imaging with 18F-FLT PET Receives: Procedure: Imaging with 18F-FLT PET |
| 5. esophagus | Experimental | Imaging with 18F-FLT PET Receives: Procedure: Imaging with 18F-FLT PET |
| 1.CNS | Experimental | Imaging with 18F-FLT PET Receives: Procedure: Imaging with 18F-FLT PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging
Measured: end of study
Secondary outcomes (1)
To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS Brain MetastasisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Jeraj, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585741
- Sponsor's protocol ID
- HSC-2006-0280
- Status last verified
- Feb 2012
- First submitted
- 21 Dec 2007
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 18F-FLT Pet Imaging in Cancer Patients
- ClinicalTrials.gov ID
- NCT00585741
- Acronym / sponsor ID
- HSC-2006-0280
- Conditions
- CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jan 2008 (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.
Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2. Head and neck | Experimental | Procedure: Imaging with 18F-FLT PETImaging with 18F-FLT PET |
| 3. Lung | Experimental | Procedure: Imaging with 18F-FLT PETImaging with 18F-FLT PET |
| 4. prostate | Experimental | Procedure: Imaging with 18F-FLT PETImaging with 18F-FLT PET |
| 5. esophagus | Experimental | Procedure: Imaging with 18F-FLT PETImaging with 18F-FLT PET |
| 1.CNS | Experimental | Procedure: Imaging with 18F-FLT PETImaging with 18F-FLT PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to tolerate a PET/CT scan
- Age of 18 or older
- signed informed consent
- being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer
Key exclusion criteria (4 listed)
- Prior XRT to site being studied
- severe claustrophobia or inability to tolerate PET/CT
- unable to provide written consent
- pregnant or breastfeeding women
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 |
|---|---|---|
| Imaging with 18F-FLT PETImaging with 18F-FLT PET | Procedure or surgery | 1.CNS |
| Imaging with 18F-FLT PETImaging with 18F-FLT PET | Procedure or surgery | 2. Head and neck |
| Imaging with 18F-FLT PETImaging with 18F-FLT PET | Procedure or surgery | 3. Lung |
| Imaging with 18F-FLT PETImaging with 18F-FLT PET | Procedure or surgery | 4. prostate |
| Imaging with 18F-FLT PETImaging with 18F-FLT PET | Procedure or surgery | 5. esophagus |
Primary outcome
To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging
Time frame: end of study
1 secondary outcome
To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
Time frame: end of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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.
Robert Jeraj, Ph.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging with 18F-FLT PET in people with CNS Brain Metastasis and Head and Neck Cancer, run by University of Wisconsin, Madison 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Feb 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging (time frame: end of study). 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 23 Feb 2012.