Unique ID issued by UMIN | UMIN000051860 |
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Receipt number | R000059173 |
Scientific Title | Prospective observational study to evaluate the usefulness of photon-counting CT in diagnosing resectability of pancreatic cancer after neoadjuvant treatment |
Date of disclosure of the study information | 2023/08/12 |
Last modified on | 2023/08/08 10:56:53 |
Prospective observational study to evaluate the usefulness of photon-counting CT in diagnosing resectability of pancreatic cancer after neoadjuvant treatment
Phantom study
Prospective observational study to evaluate the usefulness of photon-counting CT in diagnosing resectability of pancreatic cancer after neoadjuvant treatment
Phantom study
Japan |
Pancreatic adenocarcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Malignancy
NO
This study aims to develop and evaluate the effectiveness of photon-counting computed tomography in diagnosing resectability of borderline or locally advanced unresectable pancreatic cancer after systemic chemotherapy or chemoradiotherapy.
Efficacy
Exploratory
Not applicable
Accuracy of diagnosis of resectability
Sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, and AUC of ROC curve for the diagnosis of resectability
Observational
Not applicable |
Not applicable |
Male and Female
All of the following (1)-(3) are met
1) Borderline resectable pancreatic cancer (BR) or locally advanced unresectable pancreatic cancer (UR-LA) with less than full circumference in contact with the relevant artery
(ii) "Untreated with prior surgery, chemotherapy, or radiation therapy" or "Already underwent systemic chemotherapy or chemoradiotherapy, but photon-counting CT images are available before the start of treatment and when the decision for surgery was made" or "Undergoing systemic chemotherapy or chemoradiotherapy, but photon counting CT images are available before the start of treatment. (c) The patient has given written consent for this study.
None
20
1st name | Shinichiro |
Middle name | |
Last name | Takahashi |
Tokai University School of Medicine
Department of Gastroenterological Surgery
259-1193
143 Shimokasuya, Isehara, Kanagawa
0463931121
shtakaha@tsc.u-tokai.ac.jp
1st name | Shinichiro |
Middle name | |
Last name | Takahashi |
Tokai University School of Medicine
Department of Gastroenterological Surgery
259-1193
143 Shimokasuya, Isehara, Kanagawa
0463931121
shtakaha@tsc.u-tokai.ac.jp
Tokai University
Tokai University
Other
Institutional Review Board for Clinical Research, Tokai University
143 Shimokasuya, Isehara, Kanagawa
143 Shimokasuya, Isehara, Kanagawa
tokai-rec@tsc.u-tokai.ac.jp
NO
東海大学医学部付属病院(神奈川県)
大分市医師会立アルメイダ病院(大分県)
2023 | Year | 08 | Month | 12 | Day |
Unpublished
Open public recruiting
2023 | Year | 02 | Month | 21 | Day |
2023 | Year | 05 | Month | 08 | Day |
2023 | Year | 05 | Month | 30 | Day |
2026 | Year | 03 | Month | 31 | Day |
I. Development of a diagnostic method for resectability using photon-counting CT
In patients enrolled in the first half of the clinical study, photon-counting CT imaging data and clinical data of R0 resectable cases and R0 unresectable cases due to local factors will be compared and examined to determine the optimal diagnostic method for resectability.
1. Exploratory study
i. Investigation of optimal tube voltage
ii. Investigation of spectral imaging useful for the diagnosis of resectability
iii. Examination of imaging findings useful for resectability diagnostics
iv. Other exploratory studies
II. Investigate the usefulness of photon-counting CT for the diagnosis of resectability.
The diagnostic accuracy sensitivity, specificity, accuracy, Positive Predictive Value, Negative Predictive Value, AUC of ROC curve) of the determined resectability diagnostic method will be examined in the latter half of the enrollment excluding the patients examined in the former part of the study.
1)Primary endpoint: Accuracy of the diagnosis of resectability.
2)Secondary endpoints: Sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, AUC of ROC curve
III. Planned research period, planned number of patients, and rationale for setting the study
Study period: From the date of approval to March 31, 2026
1. Collection period: 2 years
2. Observation period: 1 year
3. Total study period: 3 years
4. Planned number of patients: 20
2023 | Year | 08 | Month | 08 | Day |
2023 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059173
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