Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT01243333
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2010-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Multi-tracer PET Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
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:
This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patient's response to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.
II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.
III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.
IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.
OUTLINE:
Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.
II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.
III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.
IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.
OUTLINE:
Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-03665 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |