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CCR2-Targeted Imaging for Pancreatic Cancer

Phase 1
Recruiting
Led By Farrokh Dehdashti, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Borderline resectable, locally advanced, metastatic, or recurrent PDAC (cohort 1b) scheduled to undergo chemotherapy
Adult patients 18 years of age or older with 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months)
Awards & highlights

Study Summary

This trial is testing a new way to find and treat pancreatic cancer by targeting a protein called CCR2 that is found on certain immune cells. If successful, this could help improve treatment for pancreatic cancer and reduce side effects.

Who is the study for?
This trial is for adults over 18 with early-stage pancreatic cancer scheduled for surgery, or those who've had chemo and can now have surgery. It's also open to patients with advanced stages eligible for CCR2-targeted therapy. Participants must not be pregnant/nursing and should agree to a pregnancy test if applicable.Check my eligibility
What is being tested?
The trial tests a new imaging agent (64Cu-DOTA-ECLIi) combined with PET/CT scans to select patients for CCR2-targeted therapy and monitor their response. This could help avoid ineffective treatments in pancreatic cancer by identifying non-responders early on.See study design
What are the potential side effects?
Specific side effects are not listed, but participants may experience discomfort from the PET/CT scan procedure which includes lying still up to 90 minutes per session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer is advanced and I am scheduled for chemotherapy.
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I am 18 or older with early-stage pancreatic cancer and scheduled for or have had chemotherapy before surgery.
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I have advanced pancreatic cancer and am considering or have agreed to a specific therapy.
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I am not pregnant or nursing, and cannot become pregnant or am not currently pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
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
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2: CCR2-Targeted TherapyExperimental Treatment2 Interventions
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
Group II: Cohort 1b: Standard of Care Treatment ChemotherapyExperimental Treatment2 Interventions
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
Group III: Cohort 1a: Treatment Whipple/Surgical Procedure/Surgery following neoadjuvant therapyExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT
2022
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,894 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,272 Total Patients Enrolled
Farrokh Dehdashti, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

64Cu-DOTA-ECLIi Clinical Trial Eligibility Overview. Trial Name: NCT03851237 — Phase 1
Pancreatic Cancer Research Study Groups: Cohort 1a: Treatment Whipple/Surgical Procedure/Surgery following neoadjuvant therapy, Cohort 1b: Standard of Care Treatment Chemotherapy, Cohort 2: CCR2-Targeted Therapy
Pancreatic Cancer Clinical Trial 2023: 64Cu-DOTA-ECLIi Highlights & Side Effects. Trial Name: NCT03851237 — Phase 1
64Cu-DOTA-ECLIi 2023 Treatment Timeline for Medical Study. Trial Name: NCT03851237 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with utilizing 64Cu-DOTA-ECLIi for medicinal purposes?

"Due to its Phase 1 status, there are limited safety and efficacy data points on 64Cu-DOTA-ECLIi. Our team at Power has assessed that it is a 1 in terms of risk level."

Answered by AI

Are there any vacancies for the current research project?

"Affirmative. The clinicaltrial.gov data shows that this research trial is actively enrolling participants, with the original posting date of January 2nd 2019 and most recent update occurring on May 23rd 2022. 75 individuals are required for the study at a single site."

Answered by AI

To what magnitude is participation in this research endeavor?

"Affirmative. Information on clinicaltrials.gov affirms that this experiment is actively searching for participants, initially posted on January 2nd 2019 and most recently edited May 23rd 2022. It seeks to recruit 75 individuals from 1 site."

Answered by AI
~15 spots leftby Jun 2025