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A prospective study in adult patients with pituitary adenoma treated with radiotherapy excluding the hippocampal

A prospective study to evaluate the feasibility of hippocampal sparing intensity modulated radiotherapy in preserving neurocognitive functions in adult patients with pituitary adenoma.

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/11/016345
Enrollment
50
Registered
2018-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G938- Other specified disorders of brain Health Condition 2: null- Patients above 18 years of age diagnosed with pituitary adenomas.

Interventions

Intervention1: Radiotherapy: All patients will be treated using linear accelerator machine (LA), Intensity Modulated Radiotherapy Technique (IMRT) to standard doses. All patients will be treated with

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1) To evaluate feasibility of hippocampal sparing Intensity Modulated Radiotherapy for preserving neurocognitive functions in adults with pituitary adenomas. 2) To evaluate radiotherapy dose constraints for hippocampus & its correlation with neurocognitive functions. Timepoint: After the completion of the study

Secondary

MeasureTime frame
1) To evaluate changes in hippocampal perfusion using 99mECD SPECT after hippocampal sparing intensity modulated radiotherapy & its correlation with neurocognitive functions. 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. Timepoint: After the completion of the study

Countries

India

Contacts

Public ContactDr Jayant Sastri Goda

Tata Memorial Hospital

godajayantsastri@gmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026