Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas

NCT ID: NCT02205788

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-09-14

Brief Summary

The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.

Detailed Description

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease

2. Women who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrick Joseph Loehrer Sr.

OTHER

Sponsor Role: lead

Responsible Party

Patrick Joseph Loehrer Sr.

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bert O'Neil, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Other Identifiers

IUCRO-0479

Identifier Type: -

Identifier Source: org_study_id

1405049285

Identifier Type: OTHER

Identifier Source: secondary_id