Brain Tumor, PrimaryNCT04365647
Intra-operative Variation in Size of Brain Tumors After Craniotomy
An observational study of Brain Tumor, Primary, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Brain Tumor, Primary
- How many people
- 51 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2018to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Sher-i-Kashmir Institute of Medical Sciences, Soura
Srinagar, Jammu and Kashmir, 190011
About this study
Official title: Intra-operative Variation in Size of Brain Tumors After Craniotomy - Observational Comparative Imaging Study
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.
Read the 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
- 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
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor dimension change
Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain
Measured: March 2018 to November 2019
Secondary outcomes (2)
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
Measured: March 2018 to November 2019
Relationship of tumor size change with other characteristics
Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location
Measured: March 2018 to November 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Mar 2018
- Primary completion1 Nov 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheri Kashmir Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaushal Deep Singh, Sheri Kashmir Institute of Medical Sciences
- Investigators
- Abdul R Bhat, MCh, Principal investigator, Sher-i-Kashmir Institute of Medical Sciences, Soura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365647
- Sponsor's protocol ID
- SKIMS, Soura
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Variation in Size of Brain Tumors After Craniotomy - Observational Comparative Imaging Study
- ClinicalTrials.gov ID
- NCT04365647
- Acronym / sponsor ID
- SKIMS, Soura
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sheri Kashmir Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor dimension change
Time frame: March 2018 to November 2019
Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain
2 secondary outcomes
Tumor distance from dural surface
Time frame: March 2018 to November 2019
Relationship of tumor size change with other characteristics
Time frame: March 2018 to November 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul R Bhat, MCh principal investigator
Sher-i-Kashmir Institute of Medical Sciences, Soura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, Primary, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor dimension change (time frame: March 2018 to November 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.