Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003337
Status:
UNKNOWN
Last Update Posted:
2021-08-16
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkins Lymphoma
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve the ability to detect and stage non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in the detection and staging of patients with non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in the detection and staging of patients with non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the radioimmunodetection performance of the imaging agent technetium Tc 99m LL2 monoclonal antibody LymphoScan in patients with low intermediate and high grade B-cell non-Hodgkins lymphoma II Define the safety of an initial administration of technetium Tc 99m LL2 monoclonal antibody in these patients III Demonstrate that diagnostic imaging with this agent can correctly stage patients who have been diagnosed with this disease similarly to noninvasive conventional diagnostic modalities CDMs primarily CT scan and bone scan IV Demonstrate that imaging with technetium Tc 99m LL2 monoclonal antibody is at least as sensitive for detecting disease in various body sites as any other standard diagnostic imaging method V Compare patient management plans based on CDMs alone technetium Tc 99m LL2 monoclonal antibody alone and both CDMs and technetium Tc 99m LL2 monoclonal antibody VI Describe the human antimouse antibody production in these patients
OUTLINE This is an open label multicenter study After all other diagnostic studies have been completed patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody by IV injection or infused over 20-30 minutes as part of their staging procedures Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection and single photon emission computerized tomography SPECT imaging is performed between 4-8 hours following antibody injection Patients may receive a repeat injection of technetium Tc 99m LL2 monoclonal antibody Patients are followed for 3 to 6 months
PROJECTED ACCRUAL At least 100 patients will be accrued into this study
OUTLINE This is an open label multicenter study After all other diagnostic studies have been completed patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody by IV injection or infused over 20-30 minutes as part of their staging procedures Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection and single photon emission computerized tomography SPECT imaging is performed between 4-8 hours following antibody injection Patients may receive a repeat injection of technetium Tc 99m LL2 monoclonal antibody Patients are followed for 3 to 6 months
PROJECTED ACCRUAL At least 100 patients will be accrued into this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1417 | None | None | None |
| IM-D-LL2-05 | None | None | None |