Application of MRI in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970498
Collaborator
(none)
120
1
20.9
5.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI
  • Diagnostic Test: blood routine test

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

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Application of MRI Quantitative Parameters in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
acute myelosuppression group

WBC <4.0×10^9 14 days after radiotherapy

Diagnostic Test: MRI
MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed

Diagnostic Test: blood routine test
The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

chronic myelosuppression group

WBC <4.0×10^9 90 days after radiotherapy

Diagnostic Test: MRI
MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed

Diagnostic Test: blood routine test
The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

no myelosuppression group

WBC >4.0×10^9 during radiotherapy

Diagnostic Test: MRI
MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed

Diagnostic Test: blood routine test
The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

Outcome Measures

Primary Outcome Measures

  1. Changes of IDEAL-IQ sequence of MRI [1-2 weeks after radiotherapy]

    The differences of PDFF(%) between the acute myelosuppression group and no suppression group

  2. Changes of T1WI sequence of MRI [1-2 weeks after radiotherapy]

    The differences of T1WI signal intensity(IU) between the acute myelosuppression group and no suppression group

  3. Changes of DWI sequence of MRI [1-2 weeks after radiotherapy]

    The differences of DWI signal intensity(IU)between the acute myelosuppression group and no suppression group

  4. Changes of ADC map of MRI [1-2 weeks after radiotherapy]

    The differences of ADC value(mm^2/s) between the acute myelosuppression group and no suppression group

  5. Changes of IDEAL-IQ sequence of MRI [90 days after radiotherapy]

    The differences of PDFF(%) between the chronic myelosuppression group and no suppression group

  6. Changes of T1WI sequence of MRI [90 days after radiotherapy]

    The differences T1WI signal intensity(IU)between the chronic myelosuppression group and no suppression group

  7. Changes of DWI sequence of MRI [90 days after radiotherapy]

    The differences of DWI signal intensity(IU)between the chronic myelosuppression group and no suppression group

  8. Changes of ADC map of MRI [90 days after radiotherapy]

    The differences of ADC value(mm^2/s) between the chronic myelosuppression group and no suppression group

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University third hospital Beijing Beijing China 100089

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Chair: Ning Lang, Professor, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04970498
Other Study ID Numbers:
  • M2021111
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021