Rectal NeoplasmsPhase 1NCT02112162
Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery
A Phase 1 study testing fludeoxyglucose F 18, positron emission tomography and magnetic resonance imaging in people with Rectal Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- fludeoxyglucose F 18, positron emission tomography and magnetic resonance imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- 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
- Biopsy-proven adenocarcinoma of the rectum.
- Surgical candidate.
- Candidate for neoadjuvant chemotherapy.
- Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
- At least 18 years of age.
- Zubrod performance status of 0-2.
- Able to understand and willing to sign a written informed consent document.
- Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Who cannot join
- Pregnant.
- Past history of pelvic radiotherapy.
- Received prior chemotherapy for colorectal cancer.
- Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
- Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
- Renal insufficiency (defined as glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured no more than 60 days before the first research scan) which precludes safe administration of the contrast agent.
- Currently on dialysis.
- Known prior allergic reaction to gadolinium-based MR contrast agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.
- Conditions
- Rectal Neoplasms
- Being tested
- fludeoxyglucose F 18, positron emission tomography, magnetic resonance imaging, laboratory biomarker analysis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludeoxyglucose F 18Radiation
Also called 18 FDG, 18FDG, 2-F18-fluoro-2-deoxy-D-glucose, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Undergo FDG PET/MRI
positron emission tomographyDevice
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo FDG PET/MRI
magnetic resonance imagingDevice
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo FDG PET/MRI
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (FDG PET/MRI, gene expression) | Experimental | FDG PET/MRI at baseline and at 2-4 weeks before surgery (after neoadjuvant chemoradiation). Tissue samples for gene expression at baseline and during surgery Receives: Radiation: fludeoxyglucose F 18; Device: positron emission tomography; Device: magnetic resonance imaging; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FDG-PET/MR SUVmax
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Measured: Baseline to up to 2 weeks before surgery
Change in FDG-PET/MR SUVmean
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Measured: Baseline to up to 2 weeks before surgery
Change in ADCmean
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Measured: Baseline to up to 2 weeks before surgery
Radiosensitivity index
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionDec 2016
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag Parikh, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112162
- Sponsor's protocol ID
- 201401064
- Status last verified
- Dec 2016
- First submitted
- 9 Apr 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02112162
- Acronym / sponsor ID
- 201401064
- Conditions
- Rectal Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Apr 2014 (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.
This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (FDG PET/MRI, gene expression) | Experimental | Radiation: fludeoxyglucose F 18, Device: positron emission tomography, Device: magnetic resonance imaging, Other: laboratory biomarker analysisFDG PET/MRI at baseline and at 2-4 weeks before surgery (after neoadjuvant chemoradiation). Tissue samples for gene expression at baseline and during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy-proven adenocarcinoma of the rectum.
- Surgical candidate.
- Candidate for neoadjuvant chemotherapy.
- Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
- At least 18 years of age.
Key exclusion criteria (8 listed)
- Pregnant.
- Past history of pelvic radiotherapy.
- Received prior chemotherapy for colorectal cancer.
- Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
- Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
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 |
|---|---|---|
| fludeoxyglucose F 18Also: 18 FDG, 18FDG, 2-F18-fluoro-2-deoxy-D-glucose, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18Undergo FDG PET/MRI | Radiation | Diagnostic (FDG PET/MRI, gene expression) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo FDG PET/MRI | Device | Diagnostic (FDG PET/MRI, gene expression) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo FDG PET/MRI | Device | Diagnostic (FDG PET/MRI, gene expression) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (FDG PET/MRI, gene expression) |
Primary outcome
Change in FDG-PET/MR SUVmax
Time frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in FDG-PET/MR SUVmean
Time frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in ADCmean
Time frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Radiosensitivity index
Time frame: Baseline
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Parag Parikh, M.D. principal investigator
Washington University School of Medicine
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 fludeoxyglucose F 18, positron emission tomography and magnetic resonance imaging in people with Rectal Neoplasms, run by Washington University School of Medicine 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 8 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: stopped early, as of the sponsor's last update on 8 Dec 2016. 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 was stopped early (reason given: Loss of funding). 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?
Change in FDG-PET/MR SUVmax (time frame: Baseline to up to 2 weeks before surgery). The study lists 4 primary outcomes in all. 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 8 Dec 2016.