Pancreatic CancerNCT05729737
Radiographic Response to Chemotherapy in Unresected Localized Pancreatic Cancer
An observational study of Pancreatic Cancer and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Ultrasonography, First-line Chemotherapy
- What is being tested?
- Contrast-enhanced ultrasound(CEUS)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Jan 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The main inclusion criteria were histologically proven pancreatic ductal adenocarcinoma and medical fitness for first-line chemotherapy Patients were consent to receive examinations of contrast enhanced ultrasound
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Ke Lv, +86 13693332479, lvke@163.com
Yuming Shao, MD
About this study
Official title: Prediction and Evaluation of Chemotherapy Treatment Response Using Contrast Enhanced Ultrasound in Unresected Localized Pancreatic Cancer
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.
Read the detailed description
Pancreatic cancer is a highly fatal disease with a low 5-year survival rate of approximately 9% in the United States. Due to vague symptoms and early involvement of vessels, surgical treatment is only feasible for 20% of patients. First-line chemotherapy, which can improve the rate of R0 resection, is increasingly being used and is preferred in the ASCO guidelines for patients with locally advanced and borderline resectable pancreatic cancers. Early prediction and evaluation of the treatment response can provide prognostic information and enable oncologists to tailor therapeutic strategies.
Contrast-enhanced ultrasound (CEUS) is of interest for its ability to gain macrovascular and microvascular information about organs and to aid our understanding of the complexity of angiogenesis in different types of tumors. CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in pancreatic tumors even at the capillary level. Our previous studies have confirmed that the enhancement patterns of CEUS in pancreatic ductal adenocarcinoma (PDAC) have correlation with the overall survival time. Now we hypothesize that the enhancement patterns before first-line chemotherapy can predict the treatment response and the changes in the pharmacokinetics of contrast material after treatment would reflect early neovascular changes in pancreatic tumors.
The investigators plan to recruit patients who are about to receive first-line chemotherapy for pathologically diagnosed PDAC from the department of General Surgery and Medical Oncology of our hospital. The patients will receive CEUS examination before the first cycle of chemotherapy and after 2 treatment cycles. Quantitative perfusion analysis will be performed by experienced radiologists and artificial intelligence for all of the images. According to the published literature, clinical response in patients were evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) combined with the changes of serum levels of CA 19-9. Changes of CEUS quantitative perfusion parameters 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
- Conditions
- Pancreatic Cancer, Ultrasonography, First-line Chemotherapy
- Being tested
- Contrast-enhanced ultrasound(CEUS)
- Keywords
- early chemotherapy response, contrast-enhanced ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic ductal adenocarcinoma | Patients who planned to receive first-line chemotherapy for pathologically diagnosed PDAC were recruited.
Intervention:Diagnostic test:Contrast-enhanced ultrasound Receives: Diagnostic Test: Contrast-enhanced ultrasound(CEUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)
Secondary outcomes (1)
Assessment of overall survival
Overall survival (OS) was measured from time of diagnosis to death from any cause.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2022
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke Lv, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729737
- Sponsor's protocol ID
- 82171968
- Status last verified
- Dec 2022
- First submitted
- 25 Dec 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35948035Lee 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.
PubMed 30103213Zhou 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.
PubMed 34512022Zimmermann 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.
PubMed 32638040
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Evaluation of Chemotherapy Treatment Response Using Contrast Enhanced Ultrasound in Unresected Localized Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05729737
- Acronym / sponsor ID
- 82171968
- Conditions
- Pancreatic Cancer, Ultrasonography, First-line Chemotherapy
- Keywords
- early chemotherapy response, contrast-enhanced ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic cancer is a highly fatal disease with a low 5-year survival rate of approximately 9% in the United States. Due to vague symptoms and early involvement of vessels, surgical treatment is only feasible for 20% of patients. First-line chemotherapy, which can improve the rate of R0 resection, is increasingly being used and is preferred in the ASCO guidelines for patients with locally advanced and borderline resectable pancreatic cancers. Early prediction and evaluation of the treatment response can provide prognostic information and enable oncologists to tailor therapeutic strategies.
Contrast-enhanced ultrasound (CEUS) is of interest for its ability to gain macrovascular and microvascular information about organs and to aid our understanding of the complexity of angiogenesis in different types of tumors. CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in pancreatic tumors even at the capillary level. Our previous studies have confirmed that the enhancement patterns of CEUS in pancreatic ductal adenocarcinoma (PDAC) have correlation with the overall survival time. Now we hypothesize that the enhancement patterns before first-line chemotherapy can predict the treatment response and the changes in the pharmacokinetics of contrast material after treatment would reflect early neovascular changes in pancreatic tumors.
The investigators plan to recruit patients who are about to receive first-line chemotherapy for pathologically diagnosed PDAC from the department of General Surgery and Medical Oncology of our hospital. The patients will receive CEUS examination before the first cycle of chemotherapy and after 2 treatment cycles. Quantitative perfusion analysis will be performed by experienced radiologists and artificial intelligence for all of the images. According to the published literature, clinical response in patients were evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) combined with the changes of serum levels of CA 19-9. Changes of CEUS quantitative perfusion parameters 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic ductal adenocarcinoma | – | Diagnostic Test: Contrast-enhanced ultrasound(CEUS)Patients who planned to receive first-line chemotherapy for pathologically diagnosed PDAC were recruited. Intervention:Diagnostic test:Contrast-enhanced ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The main inclusion criteria were histologically proven pancreatic ductal adenocarcinoma and medical fitness for first-line chemotherapy Patients were consent to receive examinations of contrast enhanced ultrasound
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced ultrasound(CEUS)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. | Diagnostic test | Pancreatic ductal adenocarcinoma |
Primary outcome
RECIST 1.1 Therapeutic Responses to 4 cycles
Time frame: estimated to be 4 months
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.
Serum CA 19-9 Responses to 4 cycles
Time frame: estimated to be 4 months
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".
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
Time frame: Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)
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.
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
Time frame: Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)
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.
1 secondary outcome
Assessment of overall survival
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 35948035Hester 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.
- Background: PubMed 30103213Lee 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.
- Background: PubMed 34512022Zhou 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.
- Background: PubMed 32638040Zimmermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke Lv, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Lv, MD (+8613693332479, lvke@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RECIST 1.1 Therapeutic Responses to 4 cycles (time frame: estimated to be 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.