Actively Recruiting

Phase Not Applicable
Age: 18Years - 84Years
All Genders
ID02504788

A Prospective Study of Hippocampal Avoidance During Whole Brain Radiotherapy to Preserve Neurocognitive Function Decline in Patients with Brain Metastases

Led by Chang Gung Memorial Hospital · Updated on 2023-05-01

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of hippocampal-sparing whole brain radiotherapy (HS-WBRT) in patients with brain metastases or those receiving prophylactic cranial irradiation mainly for small cell lung cancer. Whole brain radiotherapy (WBRT) is known to treat both visible and microscopic brain disease but can cause neurocognitive function (NCF) decline, especially affecting memory. This study aims to see if sparing the hippocampus during WBRT can preserve cognitive function better than traditional WBRT methods. Participants will receive HS-WBRT using volumetric modulated arc therapy (VMAT) with a Linac-based RapidArc device. Treatment involves a CT scan with a thermoplastic mask for head immobilization, followed by delivering 30 Gy in 12 fractions to the whole-brain planning target volume. This approach is used either after surgery to remove tumors or to treat limited brain metastases. The focus is on conformally avoiding the hippocampus to reduce radiation damage in this critical memory area. During the study, researchers will measure changes in verbal and non-verbal memory using the WMS III test at baseline and 4 months after starting HS-WBRT. Participants will also be monitored for overall survival and brain disease progression for up to 18 months. The study includes assessments such as brain MRI or CT scans and performance evaluations to track neurocognitive changes and treatment effects over time.

CONDITIONS

Brief Title

A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline

Who Can Participate

Age: 18Years - 84Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathologically-confirmed non-hematopoietic malignancy referred for therapeutic or prophylactic whole brain radiotherapy
  • Good performance status: ECOG score of 2 or better, or Karnofsky score of at least 70%
  • No more than three brain metastatic lesions
  • Each metastatic lesion no larger than 4 cm in greatest diameter
  • Age between 18 and 84 years
Not Eligible

You will not qualify if you...

  • Presence of metastasis within 5 mm of the hippocampus as identified by MRI
  • Clinical suspicion of leptomeningeal spreading
  • Prior radiotherapy to brain or head region, including stereotactic radiosurgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2.5 weeks

Participants receive hippocampal-sparing whole brain radiotherapy using volumetric modulated arc therapy over multiple sessions.

12 treatment sessions

Follow-up

Duration - Up to 18 months

Participants are monitored for neurocognitive function and disease progression after treatment.

Visits at baseline, 4 months, and periodic assessments up to 18 months

Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Actively Recruiting

Loading map...

Research Team

C

Chi-Cheng Chuang, M.D.

S

Shinn-Yn Lin, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

Use of 18F-Fluciclovine PET to Identify Tumors in Patients W...

Brain Metastasis

Actively Recruiting

1 location

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastas...

Brain Metastases

Actively Recruiting

1 location

7T Brain MRI Scan for Micro-brain Metastasis Detection in Pa...

Small-cell Lung Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Oncological Outcomes After Hippocampus-Sparing Whole-Brain Radiotherapy in Cancer Patients With Newly Diagnosed Brain Oligometastases: A Single-Arm Prospective Observational Cohort Study in Taiwan.

Shinn-Yn Lin, Din-Li Tsan, Chi-Cheng Chuang...

https://pubmed.ncbi.nlm.nih.gov/35096584

Hippocampal dosimetry correlates with the change in neurocognitive function after hippocampal sparing during whole brain radiotherapy: a prospective study.

Ping-Fang Tsai, Chi-Cheng Yang, Chi-Cheng Chuang...

https://pubmed.ncbi.nlm.nih.gov/26654128