Trial Outcomes & Findings for Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme (NCT NCT01575275)
NCT ID: NCT01575275
Last Updated: 2018-07-31
Results Overview
Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
TERMINATED
PHASE2
8 participants
Day 1
2018-07-31
Participant Flow
Participant milestones
| Measure |
Diagnostic (Aminolevulinic Acid)
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Diagnostic (Aminolevulinic Acid)
n=8 Participants
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
Outcome measures
| Measure |
Diagnostic (Aminolevulinic Acid)
n=8 Participants
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid
|
-0.342 cc
Interval -2.604 to 1.096
|
PRIMARY outcome
Timeframe: Up to day 1Population: Outcome never analyzed. Study closed with the IRB in 2014
Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 yearPopulation: Outcome never analyzed. Closed with the IRB in 2014
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 yearsOutcome measures
| Measure |
Diagnostic (Aminolevulinic Acid)
n=8 Participants
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index
|
16 months
Interval 8.0 to 38.0
|
Adverse Events
Diagnostic (Aminolevulinic Acid)
Serious adverse events
| Measure |
Diagnostic (Aminolevulinic Acid)
n=8 participants at risk
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Nervous system disorders
Infection
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Syncope
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Diagnostic (Aminolevulinic Acid)
n=8 participants at risk
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
aminolevulinic acid: Given PO
therapeutic conventional surgery: Undergo surgery
|
|---|---|
|
Investigations
hypoalbuminemia
|
25.0%
2/8 • Number of events 3
|
|
Investigations
Hypocalcemia
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC - Meninges
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Neuropathy: Sensory
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 6
|
|
Blood and lymphatic system disorders
Low Platelets
|
25.0%
2/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
12.5%
1/8 • Number of events 1
|
|
Investigations
hyponatremia
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place