Neoplasms

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Endoscopic Ultrasound (EUS)-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor which induces the release of large amounts of cellular debris which represent a source of tumor antigens that can trigger a host adaptive immune response against the tumor.

Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Neoadjuvant chemotherapy (NAC)

Prithvi B Patil, MS

Nirav Thosani, MD

Prithvi Patil, MS

Nirav Thosani, MD, MHA

Curtis Wray, MD

Jennifer Bailey, PhD, MA

Nirav Thosani

The objectives of this study are to determine the feasibility, tolerability, and treatment effect of Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) plus standard-of-care Neoadjuvant chemotherapy (NAC) in the treatment of Pancreatic Ductal Adenocarcinoma (PDAC).

Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) and Neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.

A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer

Using the RECIST criteria, treatment response is categorized as follows:

* Complete response (CR): Disappearance of all target lesions
* Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
* Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
* Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Using the RECIST criteria, treatment response is categorized as follows:

* Complete response (CR): Disappearance of all target lesions
* Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
* Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
* Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Disease is defined as clinical evidence of local or distant recurrence.

The University of Texas Health Science Center, Houston

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Kun Wang, MD

Yuanqi Chen, MS

Kun Kun, MD

The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the first cycle of neoadjuvant chemotherapy (NAC) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.

Breast cancer is the most prevalent cancer among women worldwide. NAC has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAC is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients.

This is a multicenter, prospective cohort study of 200 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAC in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment.

1. Retrospectively collecting MRI images data, clinical and pathological information, treatment regimens, and curative effect information to build an MRI-based, multi-parametric model.
2. Evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (ROC) curve, the area under the curve (AUC), discrimination and calibration measures.

MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer

An MRI-based, Multi-parametric Model for Early Prediction of Pathological Complete Response After the First Cycle of Neoadjuvant Chemotherapy in Breast Cancer: a Multicenter, Prospective Cohort Study

The difference in tumor regression shrinkage patterns between the different treatment groups. Based on the MRI after the first cycle, the tumor SPs were grouped into three categories: CS, diffuse decrease, and no change or enlargement.

The correlation between tumor regression shrinkage patterns and treatment efficacy.

Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.

Testing the sensitivity of NeoMDSS model to predict non-pCR using the area under receiver operating characteristic curve.

Testing the difference in the tumor shrinkage patterns on magnetic resonance imaging (MRI) in triple-negative breast cancer patients receiving neoadjuvant therapy , as well as the correlation between tumor regression pattern and efficacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer	NCT04990609	Pancreatic Duct...	Endoscopic Ultr... Neoadjuvant che...	18 Years -	The University of Texas Health Science Center, Houston
MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer	NCT04909554	Breast Cancer		18 Years -	Guangdong Provincial People's Hospital

Spots Global Cancer Trial Database for neoadjuvant chemotherapy (nac)