Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750772
• Other study ID #: XW-YZ-FAPI-2019KT95
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: January 2023

Study information

• Verified date: June 2022
• 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 DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Positron-Emission Tomography
• Tumor, Solid

Intervention

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
• 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

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, 

References & Publications (10)

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. — View 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 20 — View 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. Review. — View Citation

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 [(68)Ga]Ga-DOTA-FAPI-04 and [(18)F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of can — View 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. Review. — View Citation

Kantorová I, Lipská L, Bêlohlávek O, Visokai V, Trubac M, Schneiderová 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 — View Citation

Lindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jäger 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 — View Citation

Loktev A, Lindner T, Burger EM, Altmann A, Giesel F, Kratochwil C, Debus J, Marmé F, Jäger 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. — View Citation

Petersen RK, Hess S, Alavi A, Høilund-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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