F-18-FPPRGD2 PET/CT: Pilot Phase Evaluation of Breast Cancer Patients

作者：Lagaru Andrei^*; Mosci Camila; Shen Bin; Chin Frederick T; Mittra Erik; Telli Melinda L; Gambhir Sanjiv Sam

来源：Radiology, 2014, 273(2): 549-559.

DOI：10.1148/radiol.14140028

Purpose: To present data from the first prospective pilot phase trial of breast cancer participants imaged with fluorine 18 (F-18)-2-fluoropropionyl-labeled PEGylated dimeric arginine-glycine-aspartic acid (RGD) peptide (PEG3-E[c{RGDyk}]2) (FPPRGD2), a radiopharmaceutical agent used in positron emission tomographic (PET) imaging.
Materials and Methods: The local institutional review board approved the HIPAA-compliant protocol. Written informed consent was obtained from each patient. Eight women (age range, 44-67 years; mean age, 54.3 years +/- 8.8 [standard deviation]) with newly diagnosed or recurrent breast cancer were recruited between November 2010 and February 2011. F-18-FPPRGD2 PET/computed tomographic (CT) and F-18-fluorodeoxyglucose (FDG) PET/CT examinations were performed within 3 weeks of each other. Dynamic F-18-FPPRGD2 PET and two whole-body static F-18-FPPRGD2 PET/CT scans were obtained. During this time, vital signs and electrocardiograms were recorded at regular intervals. Blood samples were obtained before the injection of F-18-FPPRGD2 and at 24 hours and 1 week after injection to evaluate for toxicity. A nonparametric version of multivariate analysis of variance was used to assess the safety outcome measures simultaneously across time points. A paired two-sample t test was performed to compare the maximum standardized uptake values (SUVmax).
Results: F-18-FPPRGD2 was well tolerated, without noticeable changes in vital signs, on electrocardiograms, or in laboratory values. A total of 30 lesions were evaluated at F-18-FDG PET/CT and F-18-FPPRGD2 PET/CT. The primary breast lesions had F-18-FPPRGD2 uptake with SUVmax of 2.4-9.4 (mean, 5.6 +/- 2.8) 60 minutes after injection, compared with F-18-FDG uptake with SUVmax of 2.8-18.6 (mean, 10.4 +/- 7.2). Metastatic lesions also showed F-18-FPPRGD2 uptake, with SUVmax of 2.4-9.7 (mean, 5.0 +/- 2.3) at 60 minutes, compared with 18F- FDG uptake with SUVmax of 2.2-14.6 (mean, 6.6 +/- 4.2).
Conclusion: Data from this pilot phase study suggest that F-18-FPPRGD2 is a safe PET radiopharmaceutical agent. Evaluation of F-18-FPPRGD2 in participants with breast cancer demonstrated significant uptake in the primary lesion and in the metastases. Larger cohorts are required to confirm these preliminary findings.

• 出版日期2014-11