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low-cost device for differentiation of brain tumours during surgery

Low cost Fluorescein guided system for malignant brain tumours

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/050549
Enrollment
30
Registered
2023-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

None listed

Sponsors

DrDYPatil Medical College Pimpri Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: were a)suspected high grade malignant brain tumours on MRI b) tumour location- tumour should be amenable for complete resection

Exclusion criteria

Exclusion criteria: a) histological diagnosis other than high grade gliomas b) tumours not amenable to complete resection â?? basal ganglia tumours, cerebellar tumours or brainstem tumours c) severe heart,liver or kidney disease d) past history of adverse reactions to FL or severe reactions to other contrast agents. e) women during the first trimester of pregnancy f) preoperative KPS (Karnofsky Performance Status) score less than 60 g) tumour diameter less than 1cm or more than 5 cm.

Design outcomes

Primary

MeasureTime frame
Four biopsy specimens will taken at the tumour margins- 2 from the fluorescent tissue and 2 from the non fluorescent tissue. Biopsies will be examined by the neuropathologist for histopathological diagnosis and will also correlated with the fluorescein uptake to calculate the sensitivity and specificity of the device.Timepoint: biopsy specimens to be taken intraoperatively

Secondary

MeasureTime frame
post operative assessment of extent of resection will be done by contrast enhanced MRI brain 72 hours after surgeryTimepoint: 72 hours after surgery

Countries

India

Contacts

Public ContactSarang Gotecha

Dr.D.Y.Patil Medical College, Pimpri, Pune

dr.sarangsgotecha@gmail.com9322288645

Outcome results

None listed

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