Rectal Cancer Stage IINCT04970498
Application of MRI in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer
An observational study of Rectal Cancer Stage II and Rectal Cancer Stage III, run by Peking University Third Hospital at 1 site in China.
Trial summary
Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer Stage II, Rectal Cancer Stage III
- What is being tested?
- MRI and blood routine test
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University
Who may be able to join
- From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University.
- There were blood routine before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy, and MRI examination including routine MRI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks and 90 days after radiotherapy.
- Each patient used the same chemotherapy regimen.
Who cannot join
- Patients with metabolic bone diseases such as hyperparathyroidism and Cushing's syndrome.
- Patients with history of pelvic radiotherapy or systemic chemotherapy.
- Patients with leukocytes below 4.0×10^9/L or long-term severe anemia before radiotherapy.
- Patients with tumor bone metastases; patients with pelvic trauma, fracture, and infectious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University third hospital
Beijing, Beijing Municipality, 100089
Ning Lang, +861082265571, langning800129@126.com
About this study
Official title: Application of MRI Quantitative Parameters in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer
Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. The risk identification model of acute and chronic myelosuppression after neoadjuvant chemoradiotherapy was established by clinical risk factors and quantitative parameters of magnetic resonance imaging, and the prediction efficiency of the model was evaluated.
Read the detailed description
The patients with locally advanced rectal cancer diagnosed in Peking University Third Hospital and undergoing neoadjuvant chemoradiotherapy were collected. The basic information of patients (including age, sex, BMI, TNM stage of rectal cancer (T2, T3 stage)) was collected. The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed, and the corresponding parameters were obtained. The white blood cell values and quantitative parameters of magnetic resonance (including T1WI, DWI signal intensity (b = 1000) and proton density fat fraction (PDFF) of sacrilium and proximal femur were collected. Patients were divided into acute myelosuppression group and non-acute myelosuppression group according to blood routine results 14 days after radiotherapy, and chronic myelosuppression group and non-chronic myelosuppression group according to blood routine results 90 days after radiotherapy. The magnetic resonance parameters difference between 1-2 weeks after radiotherapy and before radiotherapy, and the magnetic resonance parameters difference between 90 days after radiotherapy and before radiotherapy were calculated. By comparing the differences of clinical risk factors and quantitative parameters of MRI between the two groups, the meaningful variables were screened out, and the risk identification model of acute and chronic myelosuppression was established.
- Conditions
- Rectal Cancer Stage II, Rectal Cancer Stage III
- Being tested
- MRI, blood routine test
- Keywords
- Rectal Cancer, Myelosuppression, magnetic resonance imaging, IDEAL-IQ
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed
blood routine testDiagnostic test
The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| acute myelosuppression group | WBC <4.0×10^9 14 days after radiotherapy Receives: Diagnostic Test: MRI; Diagnostic Test: blood routine test | |
| chronic myelosuppression group | WBC <4.0×10^9 90 days after radiotherapy Receives: Diagnostic Test: MRI; Diagnostic Test: blood routine test | |
| no myelosuppression group | WBC >4.0×10^9 during radiotherapy Receives: Diagnostic Test: MRI; Diagnostic Test: blood routine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of IDEAL-IQ sequence of MRI
The differences of PDFF(%) between the acute myelosuppression group and no suppression group
Measured: 1-2 weeks after radiotherapy
Changes of T1WI sequence of MRI
The differences of T1WI signal intensity（IU） between the acute myelosuppression group and no suppression group
Measured: 1-2 weeks after radiotherapy
Changes of DWI sequence of MRI
The differences of DWI signal intensity（IU）between the acute myelosuppression group and no suppression group
Measured: 1-2 weeks after radiotherapy
Changes of ADC map of MRI
The differences of ADC value（mm^2/s) between the acute myelosuppression group and no suppression group
Measured: 1-2 weeks after radiotherapy
Changes of IDEAL-IQ sequence of MRI
The differences of PDFF(%) between the chronic myelosuppression group and no suppression group
Measured: 90 days after radiotherapy
Changes of T1WI sequence of MRI
The differences T1WI signal intensity（IU）between the chronic myelosuppression group and no suppression group
Measured: 90 days after radiotherapy
Changes of DWI sequence of MRI
The differences of DWI signal intensity（IU）between the chronic myelosuppression group and no suppression group
Measured: 90 days after radiotherapy
Changes of ADC map of MRI
The differences of ADC value（mm^2/s) between the chronic myelosuppression group and no suppression group
Measured: 90 days after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Feb 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer Stage IIStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Lang, Professor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970498
- Sponsor's protocol ID
- M2021111
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MRI Quantitative Parameters in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04970498
- Acronym / sponsor ID
- M2021111
- Conditions
- Rectal Cancer Stage II, Rectal Cancer Stage III
- Keywords
- Rectal Cancer, Myelosuppression, magnetic resonance imaging, IDEAL-IQ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 21 Jul 2021 (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.
Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. The risk identification model of acute and chronic myelosuppression after neoadjuvant chemoradiotherapy was established by clinical risk factors and quantitative parameters of magnetic resonance imaging, and the prediction efficiency of the model was evaluated.
Detailed description
The patients with locally advanced rectal cancer diagnosed in Peking University Third Hospital and undergoing neoadjuvant chemoradiotherapy were collected. The basic information of patients (including age, sex, BMI, TNM stage of rectal cancer (T2, T3 stage)) was collected. The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed, and the corresponding parameters were obtained. The white blood cell values and quantitative parameters of magnetic resonance (including T1WI, DWI signal intensity (b = 1000) and proton density fat fraction (PDFF) of sacrilium and proximal femur were collected. Patients were divided into acute myelosuppression group and non-acute myelosuppression group according to blood routine results 14 days after radiotherapy, and chronic myelosuppression group and non-chronic myelosuppression group according to blood routine results 90 days after radiotherapy. The magnetic resonance parameters difference between 1-2 weeks after radiotherapy and before radiotherapy, and the magnetic resonance parameters difference between 90 days after radiotherapy and before radiotherapy were calculated. By comparing the differences of clinical risk factors and quantitative parameters of MRI between the two groups, the meaningful variables were screened out, and the risk identification model of acute and chronic myelosuppression was established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute myelosuppression group | – | Diagnostic Test: MRI, Diagnostic Test: blood routine testWBC <4.0×10^9 14 days after radiotherapy |
| chronic myelosuppression group | – | Diagnostic Test: MRI, Diagnostic Test: blood routine testWBC <4.0×10^9 90 days after radiotherapy |
| no myelosuppression group | – | Diagnostic Test: MRI, Diagnostic Test: blood routine testWBC >4.0×10^9 during radiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University
Key inclusion criteria (3 listed)
- From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University.
- There were blood routine before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy, and MRI examination including routine MRI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks and 90 days after radiotherapy.
- Each patient used the same chemotherapy regimen.
Key exclusion criteria (4 listed)
- Patients with metabolic bone diseases such as hyperparathyroidism and Cushing's syndrome.
- Patients with history of pelvic radiotherapy or systemic chemotherapy.
- Patients with leukocytes below 4.0×10^9/L or long-term severe anemia before radiotherapy.
- Patients with tumor bone metastases; patients with pelvic trauma, fracture, and infectious diseases.
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 |
|---|---|---|
| MRIMRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed | Diagnostic test | acute myelosuppression group, chronic myelosuppression group, no myelosuppression group |
| blood routine testThe blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. | Diagnostic test | acute myelosuppression group, chronic myelosuppression group, no myelosuppression group |
Primary outcome
Changes of IDEAL-IQ sequence of MRI
Time frame: 1-2 weeks after radiotherapy
The differences of PDFF(%) between the acute myelosuppression group and no suppression group
Changes of T1WI sequence of MRI
Time frame: 1-2 weeks after radiotherapy
The differences of T1WI signal intensity（IU） between the acute myelosuppression group and no suppression group
Changes of DWI sequence of MRI
Time frame: 1-2 weeks after radiotherapy
The differences of DWI signal intensity（IU）between the acute myelosuppression group and no suppression group
Changes of ADC map of MRI
Time frame: 1-2 weeks after radiotherapy
The differences of ADC value（mm^2/s) between the acute myelosuppression group and no suppression group
Changes of IDEAL-IQ sequence of MRI
Time frame: 90 days after radiotherapy
The differences of PDFF(%) between the chronic myelosuppression group and no suppression group
Changes of T1WI sequence of MRI
Time frame: 90 days after radiotherapy
The differences T1WI signal intensity（IU）between the chronic myelosuppression group and no suppression group
Changes of DWI sequence of MRI
Time frame: 90 days after radiotherapy
The differences of DWI signal intensity（IU）between the chronic myelosuppression group and no suppression group
Changes of ADC map of MRI
Time frame: 90 days after radiotherapy
The differences of ADC value（mm^2/s) between the chronic myelosuppression group and no suppression group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- 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.
Ning Lang, Professor study chair
Peking University Third 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 Stage II and Rectal Cancer Stage III, run by Peking University Third Hospital 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 3 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 21 Jul 2021. 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 宁 朗, Professor (13501241339, 13501241339@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of IDEAL-IQ sequence of MRI (time frame: 1-2 weeks after radiotherapy). The study lists 8 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 21 Jul 2021.