Status:
WITHDRAWN
A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
GE Healthcare
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02193672
Start Date
August 1 2014
Last Update
July 18 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.