Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
- To define the role of pre-therapy ^64Cu-labeled
diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis
and determining the behavior of an invasive squamous cell cervical cancer in patients
with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
- To determine whether higher copper Cu 64-ATSM uptake is associated with lower
progression-free survival of these patients after chemoradiotherapy.
- To determine if higher copper Cu 64-ATSM uptake is associated with lower overall
survival of these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary
cervical tumor recurrence and a higher rate of development of distant metastatic
disease in these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of
complete metabolic response on FDG-PET/CT scan performed 3 months after completion of
radiotherapy and chemotherapy.
- To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free
survival, overall survival, primary tumor recurrence, and future development of distant
metastatic disease in these patients.
- To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node
metastasis at study entry.
- To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study
- To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers
of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN.
- To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of
post-therapy FDG-PET/CT scan.
- To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free
OUTLINE: This is a multicenter study.
Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes
later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent
standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and
brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo
FDG-PET/CT scan 3 months after completion of chemoradiotherapy.
Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used
for detecting hypoxic markers by immunohistochemistry analysis.
After completion of study intervention, patients are followed for every 3 months for 2 years
and then every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy
Farrokh Dehdashti, MD
Mallinckrodt Institute of Radiology at Washington University Medical Center
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|