臨床研究等提出・公開システム

Exploratory study on clinical applications of photon counting detector CT

PCCT study

Kobayashi Tatsushi

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa, Chiba

takobaya@east.ncc.go.jp

Sasaki Tomoaki

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa, Chiba

+81-4-7133-1111

tomosasa@east.ncc.go.jp

Recruiting

Feb. 08, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

Cohort 1

1. Voluntary written consent to participate in this study has been obtained.
2. Aged 20 years or older on the date of informed consent.
3. ECOG Performance Status is 0.
4. Expected survival of 12 weeks or more.
5. Has been diagnosed with or suspected of having a solid tumor.
6. No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
7. Renal function within 30 days before enrollment: eGFR 45 or higher (no CKD or CKD stage 1, 2, or 3a). If multiple renal function tests are available, the result of the renal test which is closest to the date of the protocol test will be used.
8. Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)
9. Continuing examination and treatment for definitive diagnosis etc. are scheduled at our hospital (National Cancer Center Hospital East).

Cohort 2, standard dose group (Criteria 1-8 are common to Cohort 1 and Cohort 2 standard groups, and only criteria 9 is added in Cohort 1. If consent is obtained, simultaneous enrollment is permitted in both Cohort 1 and Cohort 2 standard groups.)

1. Voluntary written consent to participate in this study has been obtained.
2. Aged 20 years or older on the date of informed consent.
3. ECOG Performance Status is 0.
4. Expected survival of 12 weeks or more.
5. Has been diagnosed with or suspected of having a solid tumor.
6. No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
7. Renal function within 30 days before enrollment: eGFR 45 or higher (no CKD or CKD stage 1, 2, or 3a)
8. Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)

Cohort 2, reduced dose group

1. Voluntary written consent to participate in this study has been obtained.
2. Aged 20 years or older on the date of informed consent.
3. ECOG Performance Status is 0.
4. Expected survival of 12 weeks or more.
5. Has been diagnosed with or suspected of having a solid tumor.
6. No history of hypersensitivity to iodinated contrast media and no contraindications to the use of iodinated contrast media
7. Renal function within 30 days before enrollment: eGFR ranging from 30 or higher to 44 (CKD stage 3b)
8. Those who required a contrast-enhanced CT examination at our hospital (National Cancer Center Hospital East)
9. Scheduled reevaluation of renal function test basically within the 14 days (maximum 28 days) after the protocol test.

Cohort 1 and Cohort 2 (standard dose and reduced dose groups)

1. a person with a cardiac pacemaker
2. a woman with pregnant or breastfeeding.
3. other serious acute or chronic medically significant conditions
4. When the principal investigator or co-investigator determines that enrollment in this study is inappropriate.

Cohort 2, standard dose and reduced dose groups
5. Not scheduled reevaluation of renal function test within the 30 days after the protocol test.

Both

Solid tumor

PCCT scan as a CT examination with contrast material

Head and neck cancer, lung cancer, biliary cancer, pancreatic cancer

Cohort 1 : Specificity
Cohort 2 : Image quality score

Cohort 1
Sensitivity
Positive predictive value
Negative predictive value
Image quality score (5-point scale)
Signal-to-noise ratio (SNR)
Contrast noise ratio (CNR)
CTDIvol, DLP
Adverse event rate

Cohort 2
Signal-to-noise ratio (SNR)
Contrast noise ratio (CNR)
CTDIvol, DLP
Adverse event rate
Renal function tests and change ratio of the renal function test between the pre and post-protocol tests

+81-4-7133-1111

Jan. 17, 2023

Yes

In handling data with Canon Medical Systems, Inc. as a joint research organization, medical information (image and non-image information) may be moved to Canon Medical Systems, Inc. after anonymization for image creation, measurement, etc. In such cases, the data will be moved to Box's cloud service "Box" (server storage location: Japan) or to password-protected external storage media (portable SSD or HDD). Box" has obtained Information Security Management System (ISMS) certification (ISO/IEC27001) and all files stored online are encrypted and sufficiently robust in terms of security. The use of the "Box" will be managed by a principal investigator or co-investigator in Canon Medical Systems under the responsibility of the principal investigator. Although all the information provided is anonymized, in principle, they will be managed as potentially containing sensitive personal information. The purpose of data use will be limited, and use for other purposes will be prohibited. In addition, strict controls will be applied to ensure that medical-related information is not taken outside the company without authorization.

none