Radiographic Response to Chemotherapy in Unresected Localized Pancreatic Cancer

NCT05729737 | Unknown

• 1 other identifier: 82171968
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore whether contrast-enhanced ultrasound (CEUS) can early predict and evaluate the treatment response of first-line chemotherapy in locally advanced and borderline resectable pancreatic cancers. The main questions it aims to answer are: Question 1: What quantitative parameters of CEUS performed before first-line chemotherapy can predict the early treatment response of patients with locally pancreatic cancer?Question 2: Can CEUS reflect early neovascular changes after first-line chemotherapy in pancreatic tumors? Participants will receive CEUS examination carried out by experienced operators before the first cycle of chemotherapy and after 2 treatment cycles.

Conditions

Pancreatic Cancer; Ultrasonography; First-line Chemotherapy

Keywords

early chemotherapy response; contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (4)

• RECIST 1.1 Therapeutic Responses to 4 cycles

  The patients underwent baseline and repeat MDCT imaging (after 4 cycle). Tumor response was determined by RECIST 1.1 and was defined as a \>30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion.

  estimated to be 4 months

• Serum CA 19-9 Responses to 4 cycles

  Serum CA19-9 levels were detected before chemotherapy and at the end of Cycle 4(each cycle is 21 days). Patients with normal CA19-9(\<37 U/mL) post-chemotherapy, whether normal or elevated pre-chemotherapy are defined as "Optimal CA19-9 Response".

  estimated to be 4 months

• Evaluate if tumor uptake of contrast agent is predictive of response to chemotherapy therapy measured by comparison of Peak Intensity (PI) at CEUS imaging prior to and after 2 cycles chemotherapy

  Before initiation of the chemotherapy and at the end of Cycle 2 (each cycle is 21 days) of chemotherapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time-intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA) and artificial intelligence. PI measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, serum CA 19-9 levels and repeat pathology as applicable.

  Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)

• Evaluate if the time to peak (TP) is predictive of response to chemotherapy therapy measured by comparison of TP at CEUS imaging prior to the start of first-line chemotherapy and TP at imaging performed after 2 cycles chemotherapy

  Before initiation of the chemotherapy and at the end of Cycle 2 (each cycle is 21 days) of chemotherapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time-intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA) and artificial intelligence. TP measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, serum CA 19-9 levels and repeat pathology as applicable.

  Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)

Secondary Outcomes (1)

• Assessment of overall survival

  From first day of protocol examination to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive up to 2 years

Study Arms (1)

Pancreatic ductal adenocarcinoma

Patients who planned to receive first-line chemotherapy for pathologically diagnosed PDAC were recruited. Intervention:Diagnostic test:Contrast-enhanced ultrasound

Diagnostic Test: Contrast-enhanced ultrasound(CEUS)

Interventions

Contrast-enhanced ultrasound(CEUS) DIAGNOSTIC_TEST

CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in pancreatic tumors, it is safe and widely used in liver and pancreatic disease.

Pancreatic ductal adenocarcinoma

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

The patients were diagnosed as pancreatic ductal adenocarcinoma pathologically and planned to receive first-line chemotherapy. The patients could receive regular follow up.

You may not qualify if:

• Patients with distal metastases or patients refusing chemotherapy Patients who were not suitable for contrast-enhanced ultrasound ,such as pregnant or lactating women Patients without complete clinical data

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

• Hester CA, Perri G, Prakash LR, Maxwell JE, Ikoma N, Kim MP, Tzeng CD, Smaglo B, Wolff R, Javle M, Overman MJ, Lee JE, Katz MHG. Radiographic and Serologic Response to First-Line Chemotherapy in Unresected Localized Pancreatic Cancer. J Natl Compr Canc Netw. 2022 Aug;20(8):887-897.e3. doi: 10.6004/jnccn.2022.7018.

  PMID: 35948035 BACKGROUND

• Lee YJ, Kim SH, Kang BJ, Kim YJ. Contrast-Enhanced Ultrasound for Early Prediction of Response of Breast Cancer to Neoadjuvant Chemotherapy. Ultraschall Med. 2019 Apr;40(2):194-204. doi: 10.1055/a-0637-1601. Epub 2018 Aug 13.

  PMID: 30103213 BACKGROUND

• Zhou T, Tan L, Gui Y, Zhang J, Chen X, Dai M, Xiao M, Zhang Q, Chang X, Xu Q, Bai C, Cheng Y, Xu Q, Wang X, Meng H, Jia W, Lv K, Jiang Y. Correlation Between Enhancement Patterns on Transabdominal Ultrasound and Survival for Pancreatic Ductal Adenocarcinoma. Cancer Manag Res. 2021 Aug 31;13:6823-6832. doi: 10.2147/CMAR.S307079. eCollection 2021.

  PMID: 34512022 BACKGROUND

• Zimmermann C, Distler M, Jentsch C, Blum S, Folprecht G, Zophel K, Polster H, Troost EGC, Abolmaali N, Weitz J, Baumann M, Saeger HD, Grutzmann R. Evaluation of response using FDG-PET/CT and diffusion weighted MRI after radiochemotherapy of pancreatic cancer: a non-randomized, monocentric phase II clinical trial-PaCa-DD-041 (Eudra-CT 2009-011968-11). Strahlenther Onkol. 2021 Jan;197(1):19-26. doi: 10.1007/s00066-020-01654-4. Epub 2020 Jul 7.

  PMID: 32638040 BACKGROUND

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

• Ke Lv, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Ke Lv, MD

CONTACT

+8613693332479; lvke@163.com

Xiaoyi Yan, Doctor

CONTACT

+8615098803356; yanxiaoyi0602@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: February 15, 2023
• Study Start: January 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 15, 2023

Record last verified: 2022-12

Locations

CN (1)