An interventional study of 89Zr-J591 and PET/CT Scan in Glioblastoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 26 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for humanized antibody called J591, that is attached to a radioactive material called Zirconium-89) in patients with glioblastoma multiforme.
1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.
This study's enrollment of 2 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Exclusion Criteria:
Laboratory values:
Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
Drug: 89Zr-J591 · Device: PET/CT Scan · Device: MRI · Other: Blood draw
The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.
Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.
Binding of 89Zr-J591
This will be measured by J591 uptake in PET scan.
Time frame: 1 year
| Milestone | 89Zr-J591 |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
This will be measured by J591 uptake in PET scan.
No measurements were reported for this outcome.
Collected over Up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 89Zr-J591 | 2/2 (100%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | 89Zr-J591 |
|---|---|
| Mean | 56 (51 to 60) |
| Sex: Female, Male(Participants) | 89Zr-J591 |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | 89Zr-J591 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | 89Zr-J591 |
|---|---|
| United States | 2 |
Documents are hosted by the registry — open the source record to download them.
Ran from Apr 2015 to primary completion in Aug 2018, 40 months.
Results were first posted in Mar 2019, 7 months after primary completion.
Of 129 non-industry interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 97. This study's 40 months is below that.
Counting every sponsor, half of 147 studies reached it within 54 months; a quarter within 37 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center →