A prospective study in adult patients with pituitary adenoma treated with radiotherapy excluding the hippocampal
Phase 3
- Conditions
- Health Condition 1: G938- Other specified disorders of brainHealth Condition 2: null- Patients above 18 years of age diagnosed with pituitary adenomas.
- Registration Number
- CTRI/2018/11/016345
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients must provide study-specific informed consent prior to study enrolment
2.Indication for adjuvant /radical radiotherapy
3.Patients who are treated in TMH Mumbai / ACTREC Navi Mumbai
4.Age > 18years
5.Patients consenting for the study
6.Karnofsky Performance Score of > 70
Exclusion Criteria
1. Prior history of irradiation to head & neck region
2. Contraindication to MR imaging such as implanted metal devices, severe claustrophobia etc
3. Acute medical illness requiring intensive medical care.
4. Any evidence of chronic / severe or uncontrolled medical illnesses
5. Patients with known major psychiatric illness, on antipsychotic medications and/or on electroconvulsive therapy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) To evaluate feasibility of hippocampal sparing Intensity Modulated Radiotherapy for preserving neurocognitive functions in adults with pituitary adenomas. <br/ ><br>2) To evaluate radiotherapy dose constraints for hippocampus & its correlation with neurocognitive functions. <br/ ><br>Timepoint: After the completion of the study
- Secondary Outcome Measures
Name Time Method 1) To evaluate changes in hippocampal perfusion using 99mECD SPECT after hippocampal sparing intensity modulated radiotherapy & its correlation with neurocognitive functions. <br/ ><br>2) To evaluate for any association between quality of life and doses received by different CNS structures Hippocampus, Hypothalamus, Cochlea, Optic nerve and optic chiasm. <br/ ><br>Timepoint: After the completion of the study