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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

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

Be older than 18 years old

Must not have

Unable to tolerate up to 90 min of PET/CT imaging per imaging session.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am 18 or older with early-stage pancreatic cancer and scheduled for or have had chemotherapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot stay still for 90 minutes during a scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1300

0 / 2Eligibility criteria met