A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Primary Endpoint
- Change in Tumor Uptake
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is >/= 18 years and male or female of any race/ethnicity.
- •Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements.
- •Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib, sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other molecules with antiangiogenic properties including taxol as anti-cancer therapy.
- •Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT (SGPT) </=3 x institutional upper limit of normal and 2) serum creatinine </= 2x institutional upper limit of normal.
- •Platelet count of > 75 x 10^3/μL
- •Patients may participate in clinical trials in the Phase I program.
- •Patients with any solid tumor type.
Exclusion Criteria
- •Patient is not capable of complying with study procedures.
- •Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following: 1) Confirming in medical history that the patient is postmenopausal defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: Intrauterine device (IUD), oral contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick test taken the morning of receiving the investigational agent [18F]fluciclatide.
Arms & Interventions
PET/CT + [18F]Fluciclatide
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.
Intervention: [18F] Fluciclatide (Drug)
PET/CT + [18F]Fluciclatide
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.
Intervention: PET/CT Scan (Procedure)
PET/CT + [18F]Fluciclatide
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.
Intervention: Phone Calls (Behavioral)
Outcomes
Primary Outcomes
Change in Tumor Uptake
Time Frame: After 2, four week chemotherapy cycles
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.
Secondary Outcomes
No secondary outcomes reported