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Withdrawn No phase listed Observational

Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy

ClinicalTrials.gov ID: NCT01212237

Public ClinicalTrials.gov record NCT01212237. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 8:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Study of Dose Response of Functionally Critical Brain Regions for Brain Radiotherapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Normal tissue response is critical for brain radiotherapy, especially for dose escalation which carries with it an increased incidence of radiation-induced brain injury. Although radiation toxicity and limiting dose for anatomically critical structures of the brain have been well studied and documented, little is known for functionally critical brain regions and treatment of cognitive sequelae of cranial radiotherapy is limited. The objective of this clinical protocol is to accumulate preliminary data for future studies aiming to quantify dose response for functionally critical brain regions for brain radiotherapy. We plan to achieve this objective by correlating the radiation-induced complications and radiological changes with the radiation dose to the selected functionally critical brain regions for 25 patients. Each participating patient will receive brain fMRI to identify brain regions for processing visual, working memory and language functions. The image co-registration algorithm developed previously by our group will be used to co-register these regions on the CT scans for radiotherapy treatment planning for radiation dose calculation. Radiation-induced changes in cognitive functions will be evaluated using the modified mini mental status exam (3MS) and fMRI during the routine follow-up. The knowledge derived from this study might significantly improve the quality of life and allow safer dose escalation for patients receiving brain radiotherapy.

Study identification

NCT ID
NCT01212237
Recruitment status
Withdrawn
Study type
Observational
Phase
Not listed
Enrollment
Not listed

Conditions and interventions

Conditions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 13, 2012
Primary completion
Apr 12, 2013
Completion
Apr 12, 2013
Last update posted
Jul 28, 2019

2012 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Weill Cornell Medical College New York New York 10065

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01212237, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2019 · Synced Sep 12, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01212237 live on ClinicalTrials.gov.

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