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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04367948
Other study ID # XW-FAPI-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date December 2022

Study information

Verified date April 2020
Source Beijing Cancer Hospital
Contact Xuejuan Wang, MD
Phone 86 010 88196363
Email xuejuan_wang@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma


Description:

Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- ECOG score 0 or 1

- subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery

- expected survival =12 weeks

- blood routine, liver and kidney function meet the following criteria: blood routine: WBC=4.0×109L or neutrophils =1.5×109L, PLT=100×109/L, Hb=90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil =1.5×ULT(upper limit of normal value), ALT/AST=2.5ULN or =5×ULT(subjects with liver metastasis), ALP=2.5ULN(ALP= 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT

- at least one measurable target lesion according to RECIST1.1

- women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period

- able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

- severe abnormalities of liver and kidney function;

- women preparing for pregnancy, pregnancy and lactation;

- cannot lie supine for half an hour;

- refuse to join the clinical researcher;

- suffering from claustrophobia or other mental illness;

- conditions that other researchers considered inappropriate for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
18F-FDG and 68Ga-NOTA-FAPI04 PET/CT
Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
18F-FDG and 18F-NOTA-FAPI04 PET/CT
Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SUV Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV) 60 days
Secondary SUVR the ratio of the standardized uptake value(SUVR) of 68Ga/ 18f-nota-fapi04 for the target lesion or suspected tumor lesion within each time window to that of the normal tissue corresponding to the tumor lesion or suspected tumor lesion to the standardized uptake value of 68Ga/ 18f-nota-fapi04 60 days
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