Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Lymphoma Clinical Trial

Official title:

Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04367948
• Other study ID #: XW-FAPI-001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Positron-Emission Tomography
• Tumor, Solid

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