Clinical trial · Observational
Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas
Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas
NCT02205788CI-TRIAL-00039415withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- BDI as a chemosensitivity assay on fresh tumor samples
- timeFrame
- up to 336 days
- description
- 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.
Secondary outcomes (1)
- measure
- BDI patterns and results with Response Evaluation Criteria
- timeFrame
- up to 336 days
- description
- To compare BDI patterns consistent with chemotherapy response ex-vivo to response to chemotherapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.