A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers

Background:

• Paclitaxel is a commonly used chemotherapeutic to which tumors can become resistant by failing to accumulate sufficient concentrations of the agent to be lethal to the cell.
• A noninvasive imaging test could determine the uptake of paclitaxel by tumors
• The ability to non-invasively predict chemotherapeutic uptake in solid tumors could help select patients likely to respond to treatment, estimate drug concentration within the tumor and possibly aid in the development improved of drug delivery systems and drug resistance evasion strategies.
• The PET department at the NIH developed an efficient procedure for fluorination of paclitaxel to [18F]-labeled paclitaxel (FPAC) and studied its biodistribution in rats and mice.
• Initial preclinical data shows the biodistribution of FPAC to be similar to that of paclitaxel. It is proposed that the uptake kinetics of FPAC in vivo using PET imaging will be representative of the uptake kinetics of paclitaxel
• First in human studies were performed by the PI (Kurdziel, KA) while at Virginia Commonwealth University, Richmond VA in three normal volunteers and three breast cancer patients with no adverse events. Human dosimetry estimates were obtained.
• PET/CT imaging with FPAC should permit quantitation of solid tumor uptake of the agent, which in turn should parallel paclitaxel solid tumor kinetics.
• The physiological distribution of the agent limits its use below the diaphragm. Thus, lung and breast cancers, which tend to be sensitive to taxanes, are the target tumors in this study. Adrenal and renal tumors, which tend to be insensitive to taxanes are being included as negative-control tumors.

Primary Objectives:

• Determine if the FPAC uptake in tumors is different than the uptake in normal background tissues
• Determine safety of FPAC administration

Eligibility: