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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer Stage II; Rectal Cancer Stage III
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: 宁 朗, Professor; Phone Number: 13501241339; Email: 13501241339@126.com
• Study Contact Backup: Name: Ning 朗, Professor; Phone Number: 13501241339; Email: 13501241339@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100089
      • Recruiting
      • Peking University Third Hospital
      • Contact: Ning Lang; Phone Number: +861082265571; Email: langning800129@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of IDEAL-IQ sequence of MRI	The differences of PDFF(%) between the acute myelosuppression group and no suppression group	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	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	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	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	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	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	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	90 days after radiotherapy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; Rectal Cancer; Myelosuppression; IDEAL-IQ
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: M2021111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No