Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)

NCT06531681 | Recruiting

• 1 other identifier: 2024-K35-01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Aim to observe the application of MR-Linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,Characteristics of dosimetric parameters etc.

Conditions

Overall Response Rate; Oncology; Radiation Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• overall response rate

  The proportion of patients whose tumor volume reduction reached the predetermined value and maintained the minimum time limit requirement was the sum of CR (Complete Response) and PR (Partial Response) proportions.

  3months， 6months，12months，24months，36months，60months

Secondary Outcomes (8)

• Progression-Free Survival

  3months， 6months，12months，24months，36months，60months

• Disease Control Rate

  3months， 6months，12months，24months，36months，60months

• Overall survival

  3months， 6months，12months，24months，36months，60months

• Incidence of adverse reactions

  3months， 6months，12months，24months

• Patient reported Health related quality of life (HRQoL)

  3months，6months，12months，24months

Interventions

MR-Linac DEVICE

Radiation therapy with the MR-Linac

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will receive or have completed imaging or treatment procedures at MR-Linac, Department of Radiotherapy, Second Affiliated Hospital of Hainan Medical University, age 18-75 years, male or female, ECOG score 0-2, life expectancy \> 6 months.

You may qualify if:

• Patients are undergoing or have undergone imaging or treatment at the MR linac;
• Age 18-75 years, male or female;
• ECOG score 0-2, life expectancy \> 6 months;
• Patients provide written informed consent.

You may not qualify if:

• Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;
• The presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy;
• Acute inflammatory disease requiring systemic therapy;
• The presence of active infectious disease;
• Pregnant women, nursing mothers, and patients planning to have children during the study period.

Sponsors & Collaborators

• The Second Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, 570311, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• yuecan zeng, doctor

  The Second Affiliated Hospital of Hainan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

junnv xu, doctor

CONTACT

18208946196; xujunnv@sina.com

yuecan zeng, doctor

CONTACT

19946610752; wellyy2005@hainmc.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 1, 2024
• Study Start: August 19, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)