Rectal CancerNCT02651701
Rectal Cancer Staging Using Whole Body MR-PET
An observational study of Rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal… 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?
- MR-PET
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 30 Nov 2019
- 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: Adult patients newly diagnosed with rectal cancer.
Who may be able to join
- Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
- Patients who sign informed consent.
Who cannot join
- Patients who are contraindication for CECT
- Patients who are contraindication for MRI/CE-MRI
- patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
- Patients who were already diagnosed with an active other cancers.
- Premenopausal female patients who are pregnant.
- Patients with fasting serum glucose level (>200mg/dL) on blood glucose meter prior to WB MR-PET.
- Patients who are physically compromised to undergo WB MR-PET.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- MR-PET
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-PETProcedure or surgery
whole body MR-PET with dedicated liver+rectal protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.
Measured: 12 months
Secondary outcomes (3)
incidence of recommendation for further workup after examination
incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared.
Measured: 12 months
concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.
Measured: 12 months
concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion8 Aug 2017
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Jeong Hee Yoon, Seoul National University Hospital
- Investigators
- Jeong Hee Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651701
- Sponsor's protocol ID
- MRPET-CRC
- Status last verified
- Dec 2019
- First submitted
- 5 Jan 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3.
PubMed 31793850
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET
- ClinicalTrials.gov ID
- NCT02651701
- Acronym / sponsor ID
- MRPET-CRC
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 11 Jan 2016 (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 measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients newly diagnosed with rectal cancer.
Key inclusion criteria (2 listed)
- Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
- Patients who sign informed consent.
Key exclusion criteria (7 listed)
- Patients who are contraindication for CECT
- Patients who are contraindication for MRI/CE-MRI
- patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
- Patients who were already diagnosed with an active other cancers.
- Premenopausal female patients who are pregnant.
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 |
|---|---|---|
| MR-PETwhole body MR-PET with dedicated liver+rectal protocol | Procedure or surgery | – |
Primary outcome
the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
Time frame: 12 months
the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.
3 secondary outcomes
incidence of recommendation for further workup after examination
Time frame: 12 months
concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.
Time frame: 12 months
concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up
Time frame: 18 months
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 12 Dec 2019.
- Derived from this study: PubMed 31793850Yoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3.
- Individual participant dataSharing planned: No
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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.
Jeong Hee Yoon, MD principal investigator
Seoul National University Hospital
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 Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 12 Dec 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 South Korea. 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 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?
the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651701, which also lists 1 linked publication.
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 12 Dec 2019.