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Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Primary Purpose

Tumor, Solid, Positron-Emission Tomography, Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

18F-FDG and 68Ga-NOTA-FAPI04 PET/CT

18F-FDG and 18F-NOTA-FAPI04 PET/CT

About this trial

This is an interventional diagnostic trial for Tumor, Solid focused on measuring Lymphoma, Positron-Emission Tomography, FAPI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

68Ga-NOTA-FAPI04

18F-NOTA-FAPI04

Arm Description

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

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

Outcomes

Primary Outcome Measures

SUV

Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04367948

First Posted

April 26, 2020

Last Updated

April 26, 2020

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT04367948

Brief Title

Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Official Title

Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumor, Solid, Positron-Emission Tomography, Lymphoma

Keywords

Lymphoma, Positron-Emission Tomography, FAPI

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga-NOTA-FAPI04

Arm Type

Experimental

Arm Description

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

Arm Title

18F-NOTA-FAPI04

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

18F-FDG and 68Ga-NOTA-FAPI04 PET/CT

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

18F-FDG and 18F-NOTA-FAPI04 PET/CT

Intervention Description

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

Primary Outcome Measure Information:

Title

SUV

Description

Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)

Time Frame

60 days

Secondary Outcome Measure Information:

Title

SUVR

Description

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuejuan Wang, MD

Phone

86 010 88196363

xuejuan_wang@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi Yang, PhD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Director

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xuejuan Wang, MD

Phone

86 10-88196363

xuejuan_wang@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32632460

Citation

Wang G, Jin X, Zhu H, Wang S, Ding J, Zhang Y, Yang Z, Wang X. 68Ga-NOTA-FAPI-04 PET/CT in a patient with primary gastric diffuse large B cell lymphoma: comparisons with [18F] FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):647-648. doi: 10.1007/s00259-020-04946-0. Epub 2020 Jul 6. No abstract available.

Results Reference

derived

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Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

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