Rectal AdenocarcinomaRectal PET/MRINCT02233595
Evaluation of Rectal Cancer Treatment Response Using PET/MRI
An observational study of Rectal Adenocarcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Chemoradiation
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2014to 28 Jan 2018
- Phase
- Observational
- 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
Study population: 20 patients with newly diagnosed rectal adenocarcinoma
Who may be able to join
- A diagnosis of histopathologically confirmed rectal adenocarcinoma.
- Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
- Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
- Age ≥18.
- Ability to understand a written informed consent document and the willingness to sign it.
- Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
- Neoadjuvant chemoradiation prior to resection is planned..
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Who cannot join
- ERUS tumor state of T1.
- Radiographic evidence of metastatic disease
- Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
- Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
- Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
- Prior history of pelvic radiation.
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- Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
- Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) < 30 mLs/min), which is a contraindication to gadolinium containing contrast.
- Known allergy to gadolinium containing contrast agents.
- Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
- Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Imaging Center at China Basin
San Francisco, California, 94107
About this study
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Chemoradiation
- Keywords
- MRI, PET, rectal cancer, adjuvant chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy | Not described Receives: Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in SUVmax
To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
Measured: 2 months
tumor volume
To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start15 Oct 2014
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233595
- Sponsor's protocol ID
- 144513
- Other IDs
- NCI-2015-00980
- Acronym
- Rectal PET/MRI
- Status last verified
- Aug 2019
- First submitted
- 3 Sep 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rectal Cancer Treatment Response Using PET/MRI
- ClinicalTrials.gov ID
- NCT02233595
- Acronym / sponsor ID
- Rectal PET/MRI / 144513
- Conditions
- Rectal Adenocarcinoma
- Keywords
- MRI, PET, rectal cancer, adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 8 Sep 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.
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy | – | Radiation: Chemoradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with newly diagnosed rectal adenocarcinoma
Key inclusion criteria (8 listed)
- A diagnosis of histopathologically confirmed rectal adenocarcinoma.
- Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
- Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
- Age ≥18.
- Ability to understand a written informed consent document and the willingness to sign it.
Key exclusion criteria (11 listed)
- ERUS tumor state of T1.
- Radiographic evidence of metastatic disease
- Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
- Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
- Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
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 |
|---|---|---|
| Chemoradiation | Radiation | Adjuvant chemotherapy |
Primary outcome
change in SUVmax
Time frame: 2 months
To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
tumor volume
Time frame: 2 months
To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
Results and safety
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
Thomas Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Adenocarcinoma, run by University of California, San Francisco 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 11 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 13 Aug 2019. 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 (reason given: Low Accrual). 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 SUVmax (time frame: 2 months). The study lists 2 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 13 Aug 2019.