PCCT study

JRCT ID: jRCTs032220618

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumor
• Date of first enrollment: 08/02/2023
• Target sample size: 360
• Study type: Interventional
• Intervention(s): PCCT scan as a CT examination with contrast material

Outcome(s)

Primary Outcome

Cohort 1 : Specificity
Cohort 2 : Image quality score

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 3 days (maximum 7 days in case of the weekend) after the protocol test.

Exclude criteria

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.

Related Information

• Primary Sponsor: Kobayashi Tatsushi
• Source(s) of Monetary Support: Canon Medical Systems