DWI-MRINCT03088163
The Value of Diffusion-weighted Imaging in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
A study testing Diffusion weighted magnetic resonance imaging in people with DWI-MRI, run by Fudan University at 1 site in China.
Trial summary
The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DWI-MRI
- What is being tested?
- Diffusion weighted magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- Eastern Cooperative Oncology Group performance status of 0 to 2
- life expectancy of ≥ 3 months
- at least one measurable liver metastatic lesion in MRI (≥10mm)
- have adequate bone marrow, hepatic, and renal function
- previously received no palliative chemotherapy
Who cannot join
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- patients with symptomatic brain metastases
- active clinical severe infection
- have contraindication of MRI screening
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Wei Jian Guo, 13816066360, mingzhuhuang0718@163.com
About this study
Official title: The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.
- Conditions
- DWI-MRI
- Being tested
- Diffusion weighted magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion weighted magnetic resonance imagingDevice
Also called DWI-MRI
The enrolled colorectal liver metastases patients will receive DWI-MRI screening to evaluate the liver metastases before the chemotherapy, after the first cycle of chemotherapy and in the regular efficacy evaluation time, respectively.
| Study group | Role | What they receive |
|---|---|---|
| DWI-MRI | Experimental | Not described Receives: Device: Diffusion weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
the response rate predicted by DWI-MRI
Measured: 2 months
Secondary outcomes (2)
Progression free survival
Measured: 2 months
Overall survival
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 posted23 Mar 2017
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DWI-MRIStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- Weijian Guo, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088163
- Sponsor's protocol ID
- FDZL-MRinCLM
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03088163
- Acronym / sponsor ID
- FDZL-MRinCLM
- Conditions
- DWI-MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Mar 2017 (actual)
- 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 study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DWI-MRI | Experimental | Device: Diffusion weighted magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- Eastern Cooperative Oncology Group performance status of 0 to 2
- life expectancy of ≥ 3 months
- at least one measurable liver metastatic lesion in MRI (≥10mm)
- have adequate bone marrow, hepatic, and renal function
Key exclusion criteria (4 listed)
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- patients with symptomatic brain metastases
- active clinical severe infection
- have contraindication of MRI screening
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 |
|---|---|---|
| Diffusion weighted magnetic resonance imagingAlso: DWI-MRIThe enrolled colorectal liver metastases patients will receive DWI-MRI screening to evaluate the liver metastases before the chemotherapy, after the first cycle of chemotherapy and in the regular efficacy evaluation time, respectively. | Device | DWI-MRI |
Primary outcome
Response rate
Time frame: 2 months
the response rate predicted by DWI-MRI
2 secondary outcomes
Progression free survival
Time frame: 2 months
Overall survival
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- 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.
Weijian Guo principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion weighted magnetic resonance imaging in people with DWI-MRI, run by Fudan University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 23 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijian Guo (8621-64175590, mingzhuhuang0718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 2 months). 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 Mar 2017.