CCR2 PET for Pancreatic Cancer Imaging and Prediction of Response to Standard and CCR2-Targeted Therapy
NCT ID: NCT03851237
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2019-01-02
2025-12-19
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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 therapy.
No interventions assigned to this group
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 (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
64Cu-DOTA-ECLIi
-The first four patients enrolled on study will undergo an additional delayed imaging time point approximately 2-6 hours following 64Cu-DOTA-ECL1i
PET/CT
-Standard of care
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 protocol (tissue to be used for CCR2 expression) --Additional 64Cu-DOTA-ECL1i-PET/CT imaging after 2 cycles of therapy
64Cu-DOTA-ECLIi
-The first four patients enrolled on study will undergo an additional delayed imaging time point approximately 2-6 hours following 64Cu-DOTA-ECL1i
PET/CT
-Standard of care
Interventions
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64Cu-DOTA-ECLIi
-The first four patients enrolled on study will undergo an additional delayed imaging time point approximately 2-6 hours following 64Cu-DOTA-ECL1i
PET/CT
-Standard of care
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed early-staged localized pancreatic ductal adenocarcinoma (PDAC) scheduled to undergo Whipple procedure (cohort 1a) or down-staged after neoadjuvant chemotherapy now eligible to undergo resection OR
* borderline resectable, locally advanced, metastatic, or recurrent PDAC (cohort 1b) scheduled to undergo chemotherapy OR
* borderline resectable, locally advanced PDAC (cohort 2) who is eligible and / or signed consent to undergo CCR2-targeted therapy example:\[(phase 1/2 clinical trial combining an oral CCR2/5i (BMS-813160) with chemotherapy (gemcitabine plus nab-paclitaxel) and anti-PD-1 (nivolumab), PI, Dr. Kian Lim) HRPO #201806007 - closed to accrual March 2022\] AND
* at least one measurable \[defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI\] A cohort 1B subject who has been previously treated for PDAC with a diagnosis of recurrence and a lesion size of 1.5 cm or greater will be allowed to enroll before institution of therapy or within 20 days after starting a 2nd line or later (new therapy) for recurrent disease.
* Able to give informed consent
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-DOTA-ECL1i) is negative
Exclusion Criteria
* Unable to tolerate up to 90 min of PET/CT imaging per imaging session.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Farrokh Dehdashti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201807099
Identifier Type: -
Identifier Source: org_study_id