NCT04778345

Brief Summary

This study aims to explore the value of 68Ga-FAPI PET/CT in the diagnosis of gastric cancer peritoneal carcinomatosis in high-risk patients compared with conventional abdominal enhanced CT and 18F-FDG PET/CT. The patients with gastric adenocarcinoma (cT4/N+/M0-1) will be studied.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

February 22, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 22, 2021

Last Update Submit

February 26, 2021

Conditions

Enhanced CT18F-FDG PET/CT68Ga-FAPI PET/CTGastric CancerPeritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (2)

  • Diagnostic efficacy for peritoneal carcinomatosis

    Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT and abdominal enhanced CT

    One month after surgery

  • Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis

    SUVmax of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT

    One month after surgery

Secondary Outcomes (11)

  • Predictive value for peritoneal carcinomatosis by using radiomic algorithm

    One month after surgery

  • Diagnostic efficacy for primary lesions

    One month after surgery

  • SUVmax (for PET/CT only) for primary lesions

    One month after surgery

  • Diagnostic efficacy for metastatic lymph nodes

    One month after surgery

  • SUVmax (for PET/CT only) for metastatic lymph nodes

    One month after surgery

  • +6 more secondary outcomes

Study Arms (1)

18F-FDG PET/CT and 68Ga-FAPI PET/CT scan after abdominal enhanced CT

EXPERIMENTAL

After the patient received abdominal enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT were further performed. The interval between 18F-FDG PET/CT and 68Ga-FAPI PET/CT was 2 days to 1 week.

Diagnostic Test: 68Ga-FAPI PET/CT scan

Interventions

68Ga-FAPI PET/CT scanDIAGNOSTIC_TEST

Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging after 18F-FDG PET/CT scan during 2 days and 1 week.

18F-FDG PET/CT and 68Ga-FAPI PET/CT scan after abdominal enhanced CT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • The clinical tumor stage before PET/CT scan was evaluated as cT4/N+/M0-1, according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous abdominal inflammatory diseases (such as peritonitis, pancreatitis, cholecystitis, inflammatory bowel disease)
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
  • History of allergy to tracer agents of PET/CT
  • History of allergy to contrast agents of CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

Related Publications (14)

  • Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

    PMID: 32861308BACKGROUND

  • Roukos DH. Current status and future perspectives in gastric cancer management. Cancer Treat Rev. 2000 Aug;26(4):243-55. doi: 10.1053/ctrv.2000.0164.

    PMID: 10913380BACKGROUND

  • Burbidge S, Mahady K, Naik K. The role of CT and staging laparoscopy in the staging of gastric cancer. Clin Radiol. 2013 Mar;68(3):251-5. doi: 10.1016/j.crad.2012.07.015. Epub 2012 Sep 14.

    PMID: 22985749BACKGROUND

  • Nakagawa S, Nashimoto A, Yabusaki H. Role of staging laparoscopy with peritoneal lavage cytology in the treatment of locally advanced gastric cancer. Gastric Cancer. 2007;10(1):29-34. doi: 10.1007/s10120-006-0406-3. Epub 2007 Feb 23.

    PMID: 17334715BACKGROUND

  • Ajani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR, Sundar H; National Comprehensive Cancer Network. Gastric cancer, version 2.2013: featured updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2013 May 1;11(5):531-46. doi: 10.6004/jnccn.2013.0070.

    PMID: 23667204BACKGROUND

  • Smyth E, Schoder H, Strong VE, Capanu M, Kelsen DP, Coit DG, Shah MA. A prospective evaluation of the utility of 2-deoxy-2-[(18) F]fluoro-D-glucose positron emission tomography and computed tomography in staging locally advanced gastric cancer. Cancer. 2012 Nov 15;118(22):5481-8. doi: 10.1002/cncr.27550. Epub 2012 May 1.

    PMID: 22549558BACKGROUND

  • Garin-Chesa P, Old LJ, Rettig WJ. Cell surface glycoprotein of reactive stromal fibroblasts as a potential antibody target in human epithelial cancers. Proc Natl Acad Sci U S A. 1990 Sep;87(18):7235-9. doi: 10.1073/pnas.87.18.7235.

    PMID: 2402505BACKGROUND

  • Hamson EJ, Keane FM, Tholen S, Schilling O, Gorrell MD. Understanding fibroblast activation protein (FAP): substrates, activities, expression and targeting for cancer therapy. Proteomics Clin Appl. 2014 Jun;8(5-6):454-63. doi: 10.1002/prca.201300095. Epub 2014 Mar 24.

    PMID: 24470260BACKGROUND

  • Rettig WJ, Su SL, Fortunato SR, Scanlan MJ, Raj BK, Garin-Chesa P, Healey JH, Old LJ. Fibroblast activation protein: purification, epitope mapping and induction by growth factors. Int J Cancer. 1994 Aug 1;58(3):385-92. doi: 10.1002/ijc.2910580314.

    PMID: 7519584BACKGROUND

  • Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.

    PMID: 30954939BACKGROUND

  • 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: 32222810BACKGROUND

  • Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1.

    PMID: 33258746BACKGROUND

  • Kim JH, Jang YJ, Park SS, Park SH, Kim SJ, Mok YJ, Kim CS. Surgical outcomes and prognostic factors for T4 gastric cancers. Asian J Surg. 2009 Oct;32(4):198-204. doi: 10.1016/S1015-9584(09)60395-X.

    PMID: 19892622BACKGROUND

  • Kurita N, Shimada M, Utsunomiya T, Iwata T, Nishioka M, Yoshikawa K, Miyatani T, Higashijima J, Nakao T. Predictive factors of peritoneal metastasis in gastric cancer. Hepatogastroenterology. 2010 Jul-Aug;57(101):980-3.

    PMID: 21033263BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsPeritoneal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesAbdominal NeoplasmsPeritoneal Diseases

Study Officials

  • Chang-Ming Huang, MD

    Fujian Medical University Union Hospital

    STUDY CHAIR

Central Study Contacts

Chang-Ming Huang, MD

CONTACT

+86-13805069676hcmlr2002@163.com

Zu-Kai Wang, MD

CONTACT

+86-15659036263413966027@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 3, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

CN(1)