NCT04750772

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

February 8, 2021

Last Update Submit

June 24, 2022

Conditions

Tumor, SolidPositron-Emission TomographyColorectal Cancer

Keywords

Colorectal CancerPositron-Emission TomographyFAPI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • SUVmax

    60-120days

Study Arms (2)

68Ga-DOTA-FAPI04

EXPERIMENTAL

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

18F-DOTA-FAPI04

EXPERIMENTAL

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

Interventions

18F-FDG and 68Ga-DOTA-FAPI04 PET/CTDIAGNOSTIC_TEST

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

68Ga-DOTA-FAPI04
18F-FDG and 18F-DOTA-FAPI04 PET/CTDIAGNOSTIC_TEST

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

18F-DOTA-FAPI04

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 30850501BACKGROUND

  • 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.

    PMID: 31912902RESULT

  • 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.

    PMID: 31631858RESULT

  • 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.

    PMID: 29496096RESULT

  • 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.

    PMID: 14602860RESULT

  • 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.

    PMID: 25143865RESULT

  • 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.

    PMID: 10749239RESULT

  • 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.

    PMID: 34581274RESULT

  • 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.

    PMID: 29626119RESULT

  • 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.

    PMID: 32222810RESULT

MeSH Terms

Conditions

NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Zhi Yang

    Peking University Cancer Hospital & Institute

    STUDY DIRECTOR

Central Study Contacts

Xuejuan Wang, MD

CONTACT

86 010 88196363xuejuan_wang@hotmail.com

Zhi Yang, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Nuclear Medicine

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 11, 2021

Study Start

October 16, 2019

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)