Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Patrick Joseph Loehrer Sr.
To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
2. ≥ 18 years old at time of consent
3. Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
4. Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
5. Measurable disease by RECIST v1.1 criteria
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
7. Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
8. Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the start of protocol treatment.
9. Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
10. Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) \< 1.2, Partial thromboplastin time (PTT) in normal range, Cr \< 2.0, Total bilirubin \< 2 times upper limit normal (ULN), transaminases \< 5 times ULN
You may not be if
1. History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
2. Women who are pregnant or breastfeeding
Clareo Health | Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas
