A Phase 1 interventional study of 64Cu-DOTA-ECLIi and PET/CT in Pancreatic Ductal Adenocarcinoma, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Diagnostic
Currently there is no clinical biomarker that can be used to select patients for CCR2-targeted therapy and to monitor response to such therapy. Considering the toxicity and the rate of response to CCR2-targeted therapy, it is crucial to be able to identify patients who may not response to this therapy in order to avoid the morbidity and expense associated with ineffective therapy.
Therefore, the combination of the novel CCR2 imaging agent with the novel CCR2-targeted therapy in this trial is of great importance to promote science while prolonging the life and its quality in patients with PDAC. The investigators also believe that this combination will make substantial contributions to the fields of cancer immunotherapy and tumor monocyte/macrophage biology. Moreover, this imaging agent has the potential to not only facilitate development and testing of future CCR2-targeted therapeutic agents but also serve as a prescreen tool to select appropriate patients for imaging guided treatment.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Adult patients 18 years of age or older with:
Exclusion Criteria:
* Early-staged localized pancreatic cancer * Standard of care diagnostic biopsy * 64Cu-DOTA-ECL1i-PET/CT imaging - immediately after the dynamic study * Receive treatment with upfront surgery such as whipple procedure or surgery following neoadjuvant therapy.
* Borderline resectable, locally advanced/metastatic or recurrent pancreatic cancer * Standard of care diagnostic biopsy (if available tissue to be used for CCR2 expression) * 64Cu-DOTA-ECL1i-PET/CT imaging pretherapy * Treatment with any standard of care (SOC) chemotherapy * Additional 64Cu-DOTA-ECL1i-PET/CT imaging for patients with positive scan at baseline/early therapy at the time of standard of care follow-up imaging appointment --Additional 64Cu-DOTA-ECL1i-PET/CT imaging for patients with negative scan at baseline/early therapy at time recurrence is diagnosed by any standard imaging modality
Drug: 64Cu-DOTA-ECLIi · Device: PET/CT
* Locally advanced or borderline resectable pancreatic cancer * Biopsy per therapeutic protocol (if available tissue to be used for CCR2 expression) * 64Cu-DOTA-ECL1i-PET/CT imaging pretherapy * 2 cycles of CCR2-targeted therapy * Biopsy per therapeutic protocol (tissue to be used for CCR2 expression) --Additional 64Cu-DOTA-ECL1i-PET/CT imaging after 2 cycles of therapy
Drug: 64Cu-DOTA-ECLIi · Device: PET/CT
-The first four patients enrolled on study will undergo an additional delayed imaging time point approximately 2-6 hours following 64Cu-DOTA-ECL1i
-Standard of care
Determine whether 64Cu-DOTA-ECL1i detects CCR2 expression in PDAC tumors as measured by direct comparison of visual tumor uptake on 64Cu-DOTA-ECL1i images to CCR2 measurements in surgical specimens
* Visual tumor uptake as compared to background blood/tissue uptake: 1=no uptake, 2=mild uptake, 3=moderate uptake, and 5=striking update * Will utilize published methods of immunohistochemical staining techniques
Time frame: At any of the following time points: prior to the start of any chemotherapy or change in chemotherapy, pre-surgery without intervention or pre-surgery with intervention
Evaluate whether tumor uptake of 64Cu-DOTA-ECL1i prior to therapy (systemic therapy or surgery) or following neoadjuvant therapy prior to surgery predicts response to standard of care chemotherapy as measured by tumor SUVmax
SUVmax is a mathematical measurement of tumor burden seen on images and calculated by the following equation SUVmax= r / (a'/w) where r= radioactivity concentration in tumor (kBq/ml) as measured by the PET scanner within a defined region of interest, a'=the decay corrected amount of injected 64Cu-DOTA-ECL1i and w= weight of the patient in grams When PET imaging shows uptake of 64Cu-DOTA-ECL1i in site(s) of known tumor the SUVmax will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, laboratory values, physical examination and repeat pathology as applicable.
Time frame: Completion of first scan (day 1)
Evaluate whether tumor take of 64Cu-DOTA-ECL1i post therapy correlates with CCR2 expression and is predictive of response to therapy as measured by visual tumor uptake on 64Cu-DOTA-ECL1i images
* Visual tumor uptake as compared to background blood/tissue uptake: 1=no uptake, 2=mild uptake, 3=moderate uptake, and 5=striking update * A decrease in visual tumor uptake from baseline to post therapy imaging in cohort 2 subject is hypothesized to represent response to CCR2 directed therapy while an increase in tumor uptake is expected in cohort 1b subjects who progress while receiving standard therapy.
Time frame: Baseline and after 2 cycles of CCR directed therapy (estimated to be 2 months)
Evaluate if tumor take of 64Cu-DOTA-ECL1i is predictive of response to CCR2-directed therapy measured by comparison of SUVmax at imaging prior to the start of CCR2 directed therapy and SUVmax at imaging performed after 2 cycles of CCR2 directed therapy
* Cohort 2 only * SUVmax is a mathematical measurement of tumor burden seen on images and calculated by the following equation SUVmax= r / (a'/w) where r= radioactivity concentration in tumor (kBq/ml) as measured by the PET scanner within a defined region of interest, a'=the decay corrected amount of injected 64Cu-DOTA-ECL1i and w= weight of the patient in grams When PET imaging shows uptake of 64Cu-DOTA-ECL1i in site(s) of known tumor the SUVmax will be evaluated for change at baseline and after 2 cycles of CCR2 directed therapy. SUVmax measurements will also be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, laboratory values, physical examination and repeat pathology as applicable
Time frame: Baseline and after 2 cycles of CCR2 directed therapy (estimated to be 2 months)
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Washington University School of Medicine