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Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

Primary Purpose

Tumor, Solid, Positron-Emission Tomography, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FDG and 68Ga-DOTA-FAPI04 PET/CT
18F-FDG and 18F-DOTA-FAPI04 PET/CT
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG score 0-2
  • patients with newly diagnosed or previously treated colorectal cancers
  • patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy
  • patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging)
  • 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;

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

68Ga-DOTA-FAPI04

18F-DOTA-FAPI04

Arm Description

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

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

Outcomes

Primary Outcome Measures

finial clinical staging(TNM)
To explore the effect of FAPI PET/CT on staging of Colorectal cancer by comparing with FDG PET/CT

Secondary Outcome Measures

SUVmax
To compare the uptake (SUVmax)of two tracers (FAPI and FDG)in colorectal cancer (including the normal organs, primary tumors and metastases)

Full Information

First Posted
February 8, 2021
Last Updated
June 24, 2022
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04750772
Brief Title
Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer
Official Title
Comparison of Positron Nuclide Labeled DOTA-FAPI PET and FDG PET Study in Colocrectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers
Detailed Description
Participants first undergo an 18F-FDG PET/CT, followed by 68Ga-FAPI04 PET/CT in groups. The purpose of the study is to explore the possibility of superiority of FAPI in diagnosis of colorectal cancer (TNM staging) by the comparison of the two tracers uptake (the maximum of standardized uptake value, SUVmax). Histopathology and conventional imaging follow-up are served as the reference standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Solid, Positron-Emission Tomography, Colorectal Cancer
Keywords
Colorectal Cancer, Positron-Emission Tomography, FAPI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-DOTA-FAPI04
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
Arm Title
18F-DOTA-FAPI04
Arm Type
Experimental
Arm Description
Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG and 68Ga-DOTA-FAPI04 PET/CT
Intervention Description
Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG and 18F-DOTA-FAPI04 PET/CT
Intervention Description
Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
Primary Outcome Measure Information:
Title
finial clinical staging(TNM)
Description
To explore the effect of FAPI PET/CT on staging of Colorectal cancer by comparing with FDG PET/CT
Time Frame
60-120days
Secondary Outcome Measure Information:
Title
SUVmax
Description
To compare the uptake (SUVmax)of two tracers (FAPI and FDG)in colorectal cancer (including the normal organs, primary tumors and metastases)
Time Frame
60-120days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG score 0-2 patients with newly diagnosed or previously treated colorectal cancers patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging) 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejuan Wang, MD
Phone
86 010 88196363
Email
xuejuan_wang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, PHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi Yang
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejuan Wang, MD
Phone
86 10-88196363
Email
xuejuan_wang@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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30850501
Citation
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Results Reference
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PubMed Identifier
31631858
Citation
Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
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PubMed Identifier
29496096
Citation
Chakedis J, Schmidt CR. Surgical Treatment of Metastatic Colorectal Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):377-399. doi: 10.1016/j.soc.2017.11.010. Epub 2017 Dec 15.
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PubMed Identifier
25143865
Citation
Petersen RK, Hess S, Alavi A, Hoilund-Carlsen PF. Clinical impact of FDG-PET/CT on colorectal cancer staging and treatment strategy. Am J Nucl Med Mol Imaging. 2014 Aug 15;4(5):471-82. eCollection 2014.
Results Reference
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PubMed Identifier
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Citation
Berger KL, Nicholson SA, Dehdashti F, Siegel BA. FDG PET evaluation of mucinous neoplasms: correlation of FDG uptake with histopathologic features. AJR Am J Roentgenol. 2000 Apr;174(4):1005-8. doi: 10.2214/ajr.174.4.1741005.
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PubMed Identifier
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Citation
Borello A, Russolillo N, Lo Tesoriere R, Langella S, Guerra M, Ferrero A. Diagnostic performance of the FDG-PET/CT in patients with resected mucinous colorectal liver metastases. Surgeon. 2021 Oct;19(5):e140-e145. doi: 10.1016/j.surge.2020.09.004. Epub 2020 Oct 23.
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Citation
Lindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jager D, Mier W, Haberkorn U. Development of Quinoline-Based Theranostic Ligands for the Targeting of Fibroblast Activation Protein. J Nucl Med. 2018 Sep;59(9):1415-1422. doi: 10.2967/jnumed.118.210443. Epub 2018 Apr 6.
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Citation
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Results Reference
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Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

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