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Enhanced CTNCT04778345

Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT in Peritoneal Carcinomatosis of Gastric Cancer

A study testing 68Ga-FAPI PET/CT scan in people with Enhanced CT and 18F-FDG PET/CT, run by Fujian Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Enhanced CT, 18F-FDG PET/CT, 68Ga-FAPI PET/CT
What is being tested?
68Ga-FAPI PET/CT scan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
Mar 2021to Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Chang-Ming Huang, MD contact

+86-13805069676

hcmlr2002@163.com

Zu-Kai Wang, MD contact

+86-15659036263

413966027@qq.com

China1 site

  • Department of Gastric Surgery

    Fuzhou, Fujian

Other trials in China

About this study

Official title: Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT to Detect Peritoneal Carcinomatosis in High-Risk Patients With Gastric Cancer: A Prospective, Single-Center, Comparative Study

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.

Read the detailed description

After being informed about the study and potential risks, all patients giving written informed consent will receive 68Ga-FAPI PET/CT on the 2nd day to 1st week of 18F-FDG PET/CT. On PET/CT, omentum, peritoneum, and mesenteric lesions with increased radioactive uptake are defined as suspicious peritoneal carcinomatosis. The number of these positive lesions, the maximum standardized uptake value (SUVmax), median and range will be recorded. Subsequently, the patients will undergo laparoscopic exploration, and if radical resection is assessed, radical gastrectomy (D2 lymph node dissection) will be performed. If a radical resection is not feasible, for patients with peritoneal carcinomatosis detected, one metastasis will be taken for rapid frozen diagnosis. After the peritoneal carcinomatosis is confirmed, the metastases seen under laparoscopy will be matched with the suspicious peritoneal carcinomatosis on the three preoperative imaging examinations. The intraoperative findings are used as the gold standard to compare the detection efficiency of the three imaging examinations for peritoneal carcinomatosis. Patients with unresected tumors will receive 4 cycles of conversion therapy or neoadjuvant therapy. After the treatment, 18F-FDG PET/CT and 68Ga-FAPI PET/CT will be performed again. If necessary, patients will be subjected to a second laparoscopic exploration, and radical gastrectomy (D2 lymph node dissection) will be performed for appropriate patients. If a radical resection is still not feasible, for patients with peritoneal carcinomatosis detected, biopsy of metastases will be performed if necessary.

Being tested
68Ga-FAPI PET/CT scan
Medical subject headings
Stomach Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04778345
Study groupRoleWhat they receive
18F-FDG PET/CT and 68Ga-FAPI PET/CT scan after abdominal enhanced CTExperimentalAfter 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.
Receives: Diagnostic Test: 68Ga-FAPI PET/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: One month after surgery

  2. 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

    Measured: One month after surgery

Secondary outcomes (11)

  1. Predictive value for peritoneal carcinomatosis by using radiomic algorithm

    Prediction value of three kinds of imaging examination for peritoneal carcinomatosis by using radiomic algorithm

    Measured: One month after surgery

  2. Diagnostic efficacy for primary lesions

    Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT and abdominal enhanced CT

    Measured: One month after surgery

  3. SUVmax (for PET/CT only) for primary lesions

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

    Measured: One month after surgery

  4. Diagnostic efficacy for metastatic lymph nodes

    Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT and abdominal enhanced CT

    Measured: One month after surgery

  5. SUVmax (for PET/CT only) for metastatic lymph nodes

    SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT

    Measured: One month after surgery

  6. Correlation between the expression of fibroblast activation protein (FAP) and 68Ga-FAPI uptake in different pathological types of peritoneal carcinomatosis

    Analyzing the correlation between the SUVmax of 68Ga-FAPI in peritoneal carcinomatosis with different pathological types and FAP identified by pathological examinations

    Measured: One month after surgery

  7. Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of primary lesions

    Analyzing the correlation between the SUVmax of 68Ga-FAPI in primary lesions with different pathological types and FAP identified by pathological examinations

    Measured: One month after surgery

  8. Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of metastatic lymph nodes

    Analyzing the correlation between the SUVmax of 68Ga-FAPI in metastatic lymph nodes with different pathological types and FAP identified by pathological examinations

    Measured: One month after surgery

  9. Predictive value of conversion therapy efficacy

    Predictive value of three kinds of imaging examination for gastric cancer in conversion therapy response assessment

    Measured: One month after surgery

  10. 1-year progression-free survival rate

    The relationship between three kinds of imaging examination and the patient's 1-year progression-free survival rate

    Measured: 12 months

  11. 1-year progression patterns

    The relationship between the three types of imaging examinations and the patient's 1-year progression patterns

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study startMar 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778345
Sponsor's protocol ID
FUGES-021
Status last verified
Feb 2021
First submitted
22 Feb 2021
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32861308

  • 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.

    PubMed 10913380

  • 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.

    PubMed 22985749

  • 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.

    PubMed 17334715

  • 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.

    PubMed 23667204

  • 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.

    PubMed 22549558

  • 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.

    PubMed 2402505

  • 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.

    PubMed 24470260

  • 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.

    PubMed 7519584

  • 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.

    PubMed 30954939

  • 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.

    PubMed 32222810

  • 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.

    PubMed 33258746

  • 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.

    PubMed 19892622

  • 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.

    PubMed 21033263

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-FAPI PET/CT scan in people with Enhanced CT and 18F-FDG PET/CT, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chang-Ming Huang, MD (+86-13805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic efficacy for peritoneal carcinomatosis (time frame: One month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778345, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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