Phase
Condition
Pancreatic Cancer
Pancreatic Disorders
Treatment
64Cu-DOTA-ECLIi
PET/CT
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 afterneoadjuvant 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 clinicaltrial combining an oral CCR2/5i (BMS-813160) with chemotherapy (gemcitabineplus 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 inat least one dimension (longest diameter to be recorded) as ≥ 10 mm with CTscan or MRI] A cohort 1B subject who has been previously treated for PDAC witha diagnosis of recurrence and a lesion size of 1.5 cm or greater will beallowed to enroll before institution of therapy or within 20 days afterstarting 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 adocumented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearingpotential for whom a urine pregnancy test (with the test performed within the 24hour period immediately prior to administration of 64Cu-DOTA-ECL1i) is negative
Exclusion
Exclusion Criteria:
Patients with other invasive malignancies, with the exception of non-melanoma skincancer, who had (or have) any evidence of the other cancer present within the last 5years
Unable to tolerate up to 90 min of PET/CT imaging per imaging session.
Study Design
Connect with a study center
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
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