This clinical trial tests the safety, side effects, best dose and feasibility of using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography for the imaging of patients with PSCA-expressing pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 64Cu-DOTA A2 scFv-Fc2 DM. Because PSCA expressing pancreatic cancers take up 64Cu-DOTA A2 scFv-Fc2 DM it can be seen with PET. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography may be a safe and feasible way to obtain diagnostic images of patients with locally advanced or metastatic PSCA-expressing pancreatic cancer.
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Karnofsky > 70%
Advanced (locally or metastatic), histologically confirmed pancreatic adenocarcinoma
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Copper Cu 64-DOTA-A2DM
DrugGiven 64Cu-DOTA-A2DM IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Radioconjugate
Other interventionDOTA-A2DM IV
Incidence of adverse events
Graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 6.0.
Dose limiting toxicity
Defined as any of the following that occur during the first 2 days post the administration of radiolabeled A2DM that are attributed as possibly, probably, or definitely related to protocol therapy.
Radiolabel uptake in prominent lesions and adjacent non-tumor tissue and select organs
Measured as maximum single-voxel standardized uptake value (SUVmax) and mean standardized uptake value.
64Cu activity concentration
Ratios of tumor to non-tumor activity concentrations
Measured in the select organs (SUVmean) at different protein doses and time points will be used to determine optimal protein dose.
Imaging-based dosimetry
Quantified in the liver, spleen, heart, and the lumbar vertebrae as calculated by organ level internal dose assessment-based standard phantom data.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
