- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2019-01-02
2025-12-31
2025-12-31
75
NCT03851237
Washington University School of Medicine
Washington University School of Medicine
INTERVENTIONAL
CCR2 PET for Pancreatic Cancer Imaging and Prediction of Response to Standard and CCR2-Targeted Therapy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-02-14 | N/A | 2025-02-03 |
2019-02-19 | N/A | 2025-02-04 |
2019-02-22 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cohort 1a: Treatment Whipple/Surgical Procedure/Surgery following neoadjuvant therapy * 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 ther | DRUG: 64Cu-DOTA-ECLIi
DEVICE: PET/CT
|
| EXPERIMENTAL: Cohort 1b: Standard of Care Treatment Chemotherapy * 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 | DRUG: 64Cu-DOTA-ECLIi
DEVICE: PET/CT
|
| EXPERIMENTAL: Cohort 2: CCR2-Targeted Therapy * 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 p | DRUG: 64Cu-DOTA-ECLIi
DEVICE: PET/CT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 intervenion |
| 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. | 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. | 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 | Baseline and after 2 cycles of CCR2 directed therapy (estimated to be 2 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Farrokh Dehdashti, M.D. Phone Number: 314-362-1474 Email: dehdashtif@wustl.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
