Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

Comparison of Positron Nuclide Labeled DOTA-FAPI PET and FDG PET Study in Colocrectal Cancer

To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Positron-Emission Tomography; Tumor, Solid
• Intervention / Treatment: Diagnostic test: 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT; Diagnostic test: 18F-FDG and 18F-DOTA-FAPI04 PET/CT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 68Ga-DOTA-FAPI04; Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time	Diagnostic test: 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT; Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
EXPERIMENTAL: 18F-DOTA-FAPI04; Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time	Diagnostic test: 18F-FDG and 18F-DOTA-FAPI04 PET/CT; Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
finial clinical staging（TNM）	To explore the effect of FAPI PET/CT on staging of Colorectal cancer by comparing with FDG PET/CT	60-120days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUVmax	To compare the uptake （SUVmax）of two tracers （FAPI and FDG）in colorectal cancer (including the normal organs, primary tumors and metastases)	60-120days

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Study Director: Zhi Yang, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• Loktev A, Lindner T, Burger EM, Altmann A, Giesel F, Kratochwil C, Debus J, Marme F, Jager D, Mier W, Haberkorn U. Development of Fibroblast Activation Protein-Targeted Radiotracers with Improved Tumor Retention. J Nucl Med. 2019 Oct;60(10):1421-1429. doi: 10.2967/jnumed.118.224469. Epub 2019 Mar 8.
• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
• 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.
• 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.
• Kantorova I, Lipska L, Belohlavek O, Visokai V, Trubac M, Schneiderova M. Routine (18)F-FDG PET preoperative staging of colorectal cancer: comparison with conventional staging and its impact on treatment decision making. J Nucl Med. 2003 Nov;44(11):1784-8.
• 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.
• 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.
• 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.
• 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.
• Chen H, Pang Y, Wu J, Zhao L, Hao B, Wu J, Wei J, Wu S, Zhao L, Luo Z, Lin X, Xie C, Sun L, Lin Q, Wu H. Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Eur J Nucl Med Mol Imaging. 2020 Jul;47(8):1820-1832. doi: 10.1007/s00259-020-04769-z. Epub 2020 Mar 28.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (ACTUAL): February 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Positron-Emission Tomography; FAPI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Chelating Agents; Sequestering Agents; Fluorodeoxyglucose F18; 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
• Other Study ID Numbers: XW-YZ-FAPI-2019KT95

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No