CCR2 PET for Pancreatic Cancer Imaging and Prediction of Response to Standard and CCR2-Targeted Therapy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | January 2, 2019 |
| End Date: | May 31, 2025 |
| Contact: | Farrokh Dehdashti, M.D. |
| Email: | dehdashtif@wustl.edu |
| Phone: | 314-362-1474 |
Novel 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.
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.
Inclusion Criteria:
- Adult patients 18 years of age or older with newly diagnosed early-staged localized
pancreatic ductal adenocarcinoma (PDAC) (cohort 1a), borderline resectable, locally
advanced, or metastatic PDAC (cohort 1b) or borderline resectable, locally advanced
(cohort 2) with 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]
- Must be eligible to undergo Whipple procedure (cohort 1a) and/or standard chemotherapy
including FLFIRINOX or gemcitabine/nab-paclitaxel (Cohort 1b) OR eligible 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] (Cohort 2)
- 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:
- Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, who had (or have) any evidence of the other cancer present within the last 5
years
- Unable to tolerate up to 90 min of PET/CT imaging per imaging session.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Farrokh Dehdashti, M.D.
Phone: 314-362-1474
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials
