Rectal CancerPhase 1NCT01207895
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
A Phase 1 study testing PET imaging with [18F]-FLT and [18F]-fluorodeoxythymidine in people with Rectal Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PET imaging with [18F]-FLT and [18F]-fluorodeoxythymidine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2013
- Phase
- Phase 1
- 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
- Subjects with known rectal cancer.
- Subjects must have signed an approved consent form.
- Subjects must be 18 years of age or older.
Who cannot join
- Children less than 18 are excluded.
- Pregnant women and women who are breast feeding will be excluded from this study. A serum beta HCG will also be performed for each pre-menopausal female subject.
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Additionally, the investigators want to determine if it is possible to predict how well tumor(s) might respond to treatment with [18F]-FLT PET imaging.
- Conditions
- Rectal Cancer
- Being tested
- PET imaging with [18F]-FLT, [18F]-fluorodeoxythymidine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imaging with [18F]-FLTDevice
Up to three [18F]-FLT PET scans; one before beginning treatment, one at week three of treatment, and one at week 11, after completion of treatment but prior to surgery.
[18F]-fluorodeoxythymidineDrug
[18F]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
| Study group | Role | What they receive |
|---|---|---|
| [18F]-FLT PET scans | Experimental | Not described Receives: Device: PET imaging with [18F]-FLT; Drug: [18F]-fluorodeoxythymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
Measured: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Secondary outcomes (1)
Correlative biology
Pre-treatment and intra-treatment rectal biopsy tissue and tissue from the post-treatment surgical tumor resection will be examined for cyclin D1, TK1, PCNA, pHis-H3, thymidylate, p-Erk, p-Akt to identify changes from pre-treatment to post-treatment
Measured: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center
- Investigators
- Henry Manning, Ph.D., Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207895
- Sponsor's protocol ID
- VICC GI 0993
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
- ClinicalTrials.gov ID
- NCT01207895
- Acronym / sponsor ID
- VICC GI 0993
- Conditions
- Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Sep 2010 (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 determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Additionally, the investigators want to determine if it is possible to predict how well tumor(s) might respond to treatment with [18F]-FLT PET imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-FLT PET scans | Experimental | Device: PET imaging with [18F]-FLT, Drug: [18F]-fluorodeoxythymidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with known rectal cancer.
- Subjects must have signed an approved consent form.
- Subjects must be 18 years of age or older.
Key exclusion criteria (3 listed)
- Children less than 18 are excluded.
- Pregnant women and women who are breast feeding will be excluded from this study. A serum beta HCG will also be performed for each pre-menopausal female subject.
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
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 |
|---|---|---|
| PET imaging with [18F]-FLTUp to three [18F]-FLT PET scans; one before beginning treatment, one at week three of treatment, and one at week 11, after completion of treatment but prior to surgery. | Device | [18F]-FLT PET scans |
| [18F]-fluorodeoxythymidine[18F]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition. | Drug | [18F]-FLT PET scans |
Primary outcome
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
Time frame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
1 secondary outcome
Correlative biology
Time frame: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Henry Manning, Ph.D. principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET imaging with [18F]-FLT and [18F]-fluorodeoxythymidine in people with Rectal Cancer, run by Vanderbilt-Ingram Cancer Center 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 3 inclusion and 3 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 23 Feb 2017. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer (time frame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery). 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 2017.