Nuclear Medicine Research
Under the leadership of Leonie Gordon, M.D., nuclear medicine is pursuing a robust research program, primarily involving clinical trials of novel agents or different clinical indications for approved radiopharmaceuticals.
Clinical trials that are under way or are soon to be so:
A phase 2 assessment of the diagnostic accuracy of theTc99m MIP-1404 radiotracer in the imaging of men with high-risk prostate cancer. This trial will assess the ability of the tracer to detect both bony and lymph node metastases. The lymph node accuracy will be determined by comparison with pathology obtained from extended pelvic lymph node dissection. The accuracy of bony metastasis detection will be compared with bone scan and magnetic resonance imaging.
A randomized double-blind phase 3 trial comparing EC145 and pegylated liposomal doxorubicin in combination versus pegylated liposomal doxorubicin in participants with platinum-resistant ovarian cancer. One of the secondary aims of this trial is to see if Tc99m EC20 can detect metastases. The accuracy will be compared with computed tomography.
A multicenter, open-label, randomized phase 3 study of sequential zevalin versus observation in patients aged at least 60 years with newly diagnosed diffuse large B-cell lymphoma in PET-negative complete remission after R-CHOP or R-CHOP-like therapy.
A phase 2 study of the sensitivity and specificity of Iodine 124FIAU PET-CT in detecting prosthetic joint infection in patients presenting with pain in a prosthetic knee or hip joint. Sensitivity and specificity will be determined by correlation with pathology at the time of surgery (awaiting IRB approval).
Phase 3 trial of flurpiridaz F 18 (formerly known as BMS747158)
A novel cardiac PET imaging agent that has the potential to be an important new clinical tool for the evaluation of cardiac blood flow in patients with known or suspected coronary artery disease (CAD). Data from the Phase 2 trial showed that PET imaging with flurpiridaz F 18 had a positive safety profile and provided superior image quality, diagnostic certainty and diagnostic performance for detecting CAD compared to SPECT imaging, the current standard of care for the non-invasive detection of CAD. No serious adverse events attributable to flurpiridaz F 18 injection were reported in phase 1 or phase 2 clinical trials. In March 2011, Lantheus received a Special Protocol Assessment (SPA) approval from the FDA for the phase 3 trial of flurpiridaz F 18. The phase 3 clinical development program includes two open-label, multicenter trials to assess the diagnostic efficacy (both sensitivity and specificity) of flurpiridaz F 18 PET MPI compared with SPECT MPI in the detection of significant CAD. In June 2011, Lantheus initiated the first of the two phase 3 clinical trials of flurpiridaz F 18 in patients with suspected or known CAD. The MUSC nuclear medicine department is participating in this trial.