Intra-operative Variation in Size of Brain Tumors After C... | NCT04365647

Studies
Intra-operative Variation in Size of Brain Tumors After Craniotomy

NCT04365647

Sponsor

Sheri Kashmir Institute of Medical Sciences

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Brain Tumor, Primary

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Apr 24, 2020

First Submission Date that Met QC Criteria

Apr 24, 2020

First Posted Date

Apr 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2020

Last Update Posted Date

Apr 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain.

Detailed Description

Background: No previous study to determine the intraoperative changes in the tumor dimensions had been undertaken previously. Objectives: We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain. Study Design: This was a prospective observational study. Participants: Patients aged 15-65 years undergoing surgery at SKIMS for intraaxial parenchymal intracranial tumors were included. Methods: Standard pre-operative CECT and CEMRI brain were done to measure tumor dimensions and compared with IOUSG.

Conditions Module

Conditions

Brain Tumor, Primary

Keywords

Parenchymal brain tumors
Intraaxial brain tumors
Gliomas
Glioblastoma multiforme
Low grade glioma
High grade glioma
Intraoperative Ultrasound (IOUS)
Tumor Surfacing
Tumor expansion
Contrast enhanced magnetic resonance imaging (CEMRI) brain
Contrast enhanced computed tomography (CECT) brain

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patient's in whom there is increase in tumor size after craniotomy
2		Patient's in whom there was either no increase in tumor size or decrease in tumor size after craniotomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor dimension change	Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain	March 2018 to November 2019

Secondary Outcomes

Measure	Description	Time Frame
Tumor distance from dural surface	Change in the distance of tumor from dural surface as measured on intraoperative ultrasound when comparing it with pre-operative CEMRI and CECT brain	March 2018 to November 2019
Relationship of tumor size change with other characteristics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients above the age of 15 years conferring to Grade I and II of American Society of Anesthesiologist (ASA) physical status classification system, undergoing elective craniotomy with intracranial tumor excision were included in this study. Patients with or without any neuro-deficit were also included. Only those patients in whom all the tumor dimensions could be defined with precision on pre-operative CECT, CEMRI and IOUSG were included in the final analysis.

Exclusion Criteria:

Patients' in whom there are multiple intracranial tumors (e.g. metastasis), deep seated tumors, inability to use IOUSG and in whom exact tumor dimensions cannot be defined either on pre-operative CECT/CEMRI or on IOUSG were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients above the age of 15 years conferring to Grade I and II of American Society of Anesthesiologist (ASA) physical status classification system undergoing elective intracranial tumor surgery at our institute in the specified period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdul R Bhat, MCh	Sher-i-Kashmir Institute of Medical Sciences, Soura	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sher-i-Kashmir Institute of Medical Sciences, Soura		Srinagar	Jammu and Kashmir	190011	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D005910	Glioma
D005909	Glioblastoma

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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