Trial Outcomes & Findings for Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery (NCT NCT01394692)

Results Overview

Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

72 hours

Results posted on

2012-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intraoperative MRI tumor resection with intraoperative MRI-guidance	Conventional Group standard microsurgical tumor resection
Overall Study STARTED	29	29
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative MRI n=29 Participants tumor resection with intraoperative MRI-guidance	Conventional Group n=29 Participants standard microsurgical tumor resection	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age Continuous	57 years STANDARD_DEVIATION 13 • n=5 Participants	58 years STANDARD_DEVIATION 13 • n=7 Participants	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Germany	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.

Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved

Outcome measures

Outcome measures
Measure	Intraoperative MRI n=24 Participants tumor resection with intraoperative MRI-guidance	Conventional Group n=25 Participants standard microsurgical tumor resection
Extent of Resection	24 participants	25 participants

SECONDARY outcome

Timeframe: 6 months

Progression-free survival (radiological and/or clinical progression) at 6 months following surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Assessment of new postoperative deficits following tumor surgery

Outcome measures

Outcome data not reported

Adverse Events

Intraoperative MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christian Senft

Johann Wolfgang Goethe University

Phone: +49 69 63015939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place