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

NCT02205788 | Withdrawn DMC

• 2 other identifiers: IUCRO-04791405049285
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• BDI as a chemosensitivity assay on fresh tumor samples

  To examine the feasibility of using 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.

  up to 336 days

Secondary Outcomes (1)

• BDI patterns and results with Response Evaluation Criteria

  up to 336 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic and Cancer Clinic patients

You may qualify if:

• Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
• ≥ 18 years old at time of consent
• 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.
• 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)
• Measurable disease by RECIST v1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
• 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.
• Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
• 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 qualify if:

• History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Patrick Joseph Loehrer Sr.: lead

Biospecimen

Retention: SAMPLES WITH DNA

core needle biopsy of tumor

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Bert O'Neil, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: September 14, 2016
• Study Completion: September 14, 2016
• Last Updated: July 10, 2019

Record last verified: 2019-07