Ongoing Trials with 18F-FES PET at ClinicalTrials.gov
| Trial identifier | No. of patients | Primary outcome measures | Secondary outcome measures |
| NCT02409316 | 75 | Evaluate 18F-FES PET/CT uptake as predictor of PFS in patients who had recurrent cancer refractory to endocrine therapy or MBC and were starting new therapy regimen including endocrine therapy | Correlate 18F-FES uptake, IHC, and experimental pathology markers Evaluate utility of combined 18F-FES PET/CT and 18F-FDG PET/CT in identifying heterogeneity of ER expression and functionality in MBC Compare 18F-FES uptake at baseline and progression in patients receiving additional endocrine therapy Correlate 18F-FES uptake with CTCs and ratio of ER+ to ER− CTCs |
| NCT01986569 | 94 | Lesion-level 18F-FES PET interpretation and reference IHC testing in stage IV MBC patients | Not provided |
| NCT02398773 | 99 | Negative predictive value of 18F-FES uptake for clinical benefit in ER+, HER2− MBC patients | Evaluate relationship between 18F-FES uptake and semiquantitative ER measures 18F-FES SUVmax of <1.5 as optimal cutoff point for predicting PFS Percentage of eligible patients for whom biopsy is not feasible, i.e., predictive accuracy of 18F-FES PET/CT for PFS; significance of 18F-FES PET measures in predicting progressive disease or clinical benefit |
| NCT02149173 | 80 | Change in 18F-FES SUV in ER+ MBC patients undergoing endocrine therapy Proportion of patients experiencing threshold as percentage change | Safety profile of 18F-FES PET Correlate 18F-FES PET uptake measures with histopathologic assays and microenvironment studies of biopsy specimens |
| NCT01988324 | 20 | Concordance between PET results and IHC of biopsied lesions from ER+ MBC patients | Numbers of lesions detected on PET vs. CT and bone scanning Inter- and intrapatient variations Interobserver variation |
| NCT01627704 | 72 | Compare response rate after 6 mo of endocrine treatment in MBC patients with 18F-FES uptake in metastatic lesions | Determine whether 18F-FES PET/CT is able to detect metastases that are not visible on 18F-FDG PET/CT; determine nature of discordant 18F-FES and 18F-FDG foci; validate and improve interpretation criteria for 18F-FES PET/CT; confirm tolerance |
| NCT00816582 | 100 | Rate of clinical benefit of fulvestrant in MBC patients | Not provided |
| NCT00647790 | 79 | Preoperatively evaluate ER status of breast cancer on PET imaging in primary breast cancer patients undergoing surgery | Correlate ER positivity on PET imaging and conventional IHC |
| NCT01153672 | 8 | Determine rate of clinical benefit for patients treated with cycles of 2 wk of vorinostat and then 6 wk of aromatase inhibitor | Change in 18F-FES SUV after 2 and 8 wk Change in 18F-FDG SUV after 2 and 8 wk |
| NCT01275859 | 25 | Evaluate rate of pathologic complete response to lapatinib plus letrozole in neoadjuvant setting | Correlation of 18F-FES PET with biologic and imaging predictors of response Evaluate diagnostic value of 18F-FES PET SUV for predicting response to therapy |
| NCT01957332 | 200 | Evaluate clinical utility of experimental PET scans in setting of MBC at first presentation | Correlation PET scans with (progression-free) survival Cost-effectiveness of molecular imaging Quality of life |
PFS = progression-free survival; IHC = immunohistochemistry; CTCs = circulating tumor cells; ER+ = estrogen receptor–positive; ER− = estrogen receptor–negative.