This phase II studies whether 64 Copper (Cu)-DOTATATE (Detectnet) positron emission tomography and computed tomography (PET/CT) can be used to make 177 lutetium (Lu)-DOTATATE (Lutathera) therapy safer for patients with neuroendocrine cancer. Detectnet is an Food and Drug Administration (FDA) approved PET scan tracer used to diagnose neuroendocrine tumors (NETs). Lutathera is a treatment for neuroendocrine cancer that is currently administered to patients in a "one size fits all" manner, so some patients unfortunately experience side effects from
Lutathera which can be caused by too much radiation being delivered to healthy organs. This study will help determine if Lutathera can be administered more safely with the help of 64Cu-DOTATATE PET/CT imaging for patients with neuroendocrine cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06122610.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterStatus: Active
Contact: Steve Yoon-Ho Cho
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Steve Yoon-Ho Cho
Phone: 608-263-5048
PRIMARY OBJECTIVE:
I. Compare pre-therapy voxel-based dosimetry estimates of 177Lu-DOTATATE using 64Cu-DOTATATE as a surrogate to post-cycle-one 177Lu-DOTATATE voxel-based dosimetry.
SECONDARY OBJECTIVES:
I. Correlated normal absorbed doses with standard-of-care clinical parameters of organ function.
II. Compare three dimensional (3D) voxel-based (e.g., Torch) versus model based (e.g., OLINDA) dosimetry in patients receiving 177Lu-DOTATATE (Lutathera) using 3D single photon emission computed tomography (SPECT)/CT imaging post therapy.
III. Compare the biodistribution and pharmacokinetics of 64Cu-DOTATATE and 177Lu-DOTATATE.
IV. Predict longitudinal whole-body kinetics of 64Cu-DOTATATE using whole-body dynamic positron emission tomography (PET)/CT.
OUTLINE:
Patients receive 64Cu-DOTATATE intravenously (IV) and undergo PET/CT over 3 days post injection during visits 1 and 2. Patients also receive 177Lu-DOTATATE IV)over 1 hour and undergo SPECT/CT post injection during visit 3 and then undergo additional SPECT/CT over 4 days post injection during visits 4 and 5.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorSteve Yoon-Ho Cho
