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

NCT04970498 | Unknown

• 1 other identifier: M2021111
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer Stage II; Rectal Cancer Stage III

Keywords

Rectal Cancer; Myelosuppression; magnetic resonance imaging; IDEAL-IQ

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

acute myelosuppression group

WBC \<4.0×10\^9 14 days after radiotherapy

Diagnostic Test: MRI; Diagnostic Test: blood routine test

chronic myelosuppression group

WBC \<4.0×10\^9 90 days after radiotherapy

Diagnostic Test: MRI; Diagnostic Test: blood routine test

no myelosuppression group

WBC \>4.0×10\^9 during radiotherapy

Diagnostic Test: MRI; Diagnostic Test: blood routine test

Interventions

MRI DIAGNOSTIC_TEST

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

acute myelosuppression group; chronic myelosuppression group; no myelosuppression group

blood routine test DIAGNOSTIC_TEST

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

acute myelosuppression group; chronic myelosuppression group; no myelosuppression group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University third hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ning Lang, Professor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

宁 朗, Professor

CONTACT

13501241339; 13501241339@126.com

Ning 朗, Professor

CONTACT

13501241339; 13501241339@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 21, 2021
• Study Start: February 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)