Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment.
PET/CT Scans:
If you are found eligible to take part in this study, you will have a PET/CT scan at your treatment baseline visit, about 1 week before your first cycle of chemotherapy. You will then have a second PET/CT scan at the end of your first cycle of chemotherapy (about 3-4 weeks after starting chemotherapy).
For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A small needle and tube will be placed in your arm, and you will receive an injection of a very small amount of a mildly radioactive material into your bloodstream (the investigational tracer, [18F]fluciclatide). The radioactive nature of this injected material allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a table. The scan itself may last up to 1 hour.
Each PET/CT imaging session will last about 4 hours total from the time you arrive at the clinic until you are discharged and allowed to go home. You may be discharged 30 minutes after the scan is complete, if the doctor thinks you are clinically stable and it is safe for you to leave.
Study Visits:
If the following tests are already being performed as part of the clinical research study you are participating in or as part of standard care, they will not need to be repeated for this study.
Baseline Visit (before the first PET/CT is performed):
End of Cycle 1 (before the second PET/CT is performed):
-Blood (about 3 tablespoons) will be drawn for routine tests.
About 24 hours after each PET/CT is performed, the study staff will call you by telephone to ask about your health status and any side effects you may be experiencing.
Anytime within the next month after the second PET/CT scan, blood (about 3 tablespoons) will be drawn for routine tests.
When your chemotherapy is over, you will have a third PET/CT scan as part of your standard care, and an FDG tracer will be used for that scan.
Length of Participation:
Your study participation will end about 6 weeks after your second PET/CT scan is performed.
This is an investigational study. [18F]Fluciclatide is not FDA approved or commercially available. At this time, it is only being used in research.
Up to 50 patients will take part in this research study. All will be enrolled at MD Anderson.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT + [18F]Fluciclatide | Experimental | At baseline: Participants have PET/CT imaging within 7 days prior to initiation of chemotherapy treatment. Participants monitored at 24 hours post scan via telephone. On treatment: Participants have PET/CT imaging at end of the first cycle and prior to the initiation of the second cycle of chemotherapy. Participants assessed at 24 hours post scan via telephone call. Baseline and on treatment PET/CT imaging performed with agent [18F] Fluciclatide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F] Fluciclatide | Drug | [18F] Fluciclatide given by vein before PET/CT scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor Uptake | Primary efficacy endpoint is change in tumor uptake of investigational agent [18F]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent [18F]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles. | After 2, four week chemotherapy cycles |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Apostolia M. Tsimberidou, MD,PHD | M.D. Anderson Cancer Center | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PET/CT Scan | Procedure | PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy. |
|
|
| Phone Calls | Behavioral | Phone call to participants by study staff about 24 hours after each PET/CT is performed. |
|
| ID | Term |
|---|---|
| C530281 | AH 111585 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided