AzTrials
AzTrials

Gastric Cancer StageNCT04028375

Study of CT and MR in the Gastric Cancer

An observational study of Gastric Cancer Stage and CT, run by Henan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

It is very significant that assessing staging in gastric cancer patients before surgery, furthermore, determining the optimize surgical strategy ,predict the the efficacy of neoadjuvant therapy for patients. For patients who are ineffective in neoadjuvant therapy, surgery will be more meaningful. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Cancer Stage, CT, MRI
How many people
400 participants
Where
1 siteChina
Study dates
1 Sep 2019to 1 Dec 2023
Phase
Observational
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 80 years
  • All sexes
  • Adult, Older adult

Study population: Subjects with endoscopically biopsy-proven gastric cancer will receive treatment

Who may be able to join

  • Consecutive patients with preoperative pathologically con-firmed gastric cancer by endoscopy and preoperative imaging data (esophagography\CT\EUS\MRI) were included.
  • No contraindications for MRI examination. No contraindications contrast.
  • The patients participate in this study with informed consent.

Who cannot join

  • The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
  • The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
  • PatientsThe patients refuse to participate in the project.
  • Other situations considered by investigators not meet the inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Jinrong Qu contact

0371-65587595

qjryq@126.com

Jing Ding, Master contact

0371-65587251

dingjing201305@163.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Baoxia He, MD, 8637165588007, hnszlyygcp@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of CT and MR in Staging and Prediction of Response in Patients With Gastric Cancer

It is very significant that assessing staging in gastric cancer patients before surgery, furthermore, determining the optimize surgical strategy ,predict the the efficacy of neoadjuvant therapy for patients. For patients who are ineffective in neoadjuvant therapy, surgery will be more meaningful.

It has been reported that the application of CT(computed tomography,CT) and MR(magnetic resonance,MR) in staging of gastric cancer, but not in predicting clinical response to neoadjuvant therapy for gastric cancer. Only a few studies focused on T staging using conventional MRI in gastric cancer, however , relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with gastric cancer by utilization of the new imaging methods (T2-TSE-BLADE,T2 maps, StarVIBE, iShim-DWI and high resolution CT). By analysing the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of new technology and reference values for facilitate pre-treatment diagnosis of TN staging, optimize surgical strategy , predict the the efficacy of adjunctive therapy , and OS and define the range of lymph node for radiotherapy , as making personal treatment planning for gastric cancer .

Read the detailed description

To explore the value of CT and MR using multiple sequences, including T2-TSE-BLADE, T2 maps StarVIBE, and iShim-DWI in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with gastric cancer.

Patients with endoscopically biopsy-proven gastric cancer were prospectively enrolled for imaging on CT and a 3T MRI scanner . The MRI protocol included T2-TSE-BLADE, T2 maps,iShim-DWI(diffusion weighted imaging,DWI)and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline(the National Comprehensive Cancer Network,NCCN). Readers assigned a TN stage on CT and MRI, and post-operative pathologic confirmation was considered the gold standard.

Inter-reader agreement, the diagnostic accuracy of TN staging on CT and MRI were analyzed and compared to post-operative pathologic TN staging separately. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will include 400 patients. Inter-reader agreements of TN staging were analyzed excellent for CT and MRI. Diagnostic accuracy of CT and MRI will be calculated separately.

Being tested
No intervention
Keywords
Gastric Cancer, MRI, MSCT, Staging, Prediction and Prognosis
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • No interventionOther

    No intervention

What is being measured

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

  1. MSCT and MRI staging in Gastric Cancer.

    To evaluate the staging of gastric cancer treated with systematic therapy through MSCT and 3 T MRI which using multiple sequences.

    Measured: up to 2 year

Secondary outcomes (1)

  1. MSCT and MRI prediction of prognosis in gastric cancer

    To construct a model,a depth convolution neural network based on MSCTand multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and prognosis,could further help to improve the prediction of response and OS of gastric cancer treated with systematic therapy.

    Measured: up to 2 year

Timeline

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

  1. First posted22 Jul 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 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
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04028375
Sponsor's protocol ID
FSK002
Status last verified
Jul 2019
First submitted
17 Jul 2019
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giganti F, Tang L, Baba H. Gastric cancer and imaging biomarkers: Part 1 - a critical review of DW-MRI and CE-MDCT findings. Eur Radiol. 2019 Apr;29(4):1743-1753. doi: 10.1007/s00330-018-5732-4. Epub 2018 Oct 2.

    PubMed 30280246

  • Pang L, Wang J, Fan Y, Xu R, Bai Y, Bai L. Correlations of TNM staging and lymph node metastasis of gastric cancer with MRI features and VEGF expression. Cancer Biomark. 2018;23(1):53-59. doi: 10.3233/CBM-181287.

    PubMed 30010108

  • Borggreve AS, Goense L, Brenkman HJF, Mook S, Meijer GJ, Wessels FJ, Verheij M, Jansen EPM, van Hillegersberg R, van Rossum PSN, Ruurda JP. Imaging strategies in the management of gastric cancer: current role and future potential of MRI. Br J Radiol. 2019 May;92(1097):20181044. doi: 10.1259/bjr.20181044. Epub 2019 Mar 5.

    PubMed 30789792

  • Zhou J, Shen J, Seifer BJ, Jiang S, Wang J, Xiong H, Xie L, Wang L, Sui X. Approaches and genetic determinants in predicting response to neoadjuvant chemotherapy in locally advanced gastric cancer. Oncotarget. 2017 May 2;8(18):30477-30494. doi: 10.18632/oncotarget.12955.

    PubMed 27802185

  • Kwee RM, Kwee TC. Role of imaging in predicting response to neoadjuvant chemotherapy in gastric cancer. World J Gastroenterol. 2014 Feb 21;20(7):1650-6. doi: 10.3748/wjg.v20.i7.1650.

    PubMed 24587644

  • Ng J, Lee P. The Role of Radiotherapy in Localized Esophageal and Gastric Cancer. Hematol Oncol Clin North Am. 2017 Jun;31(3):453-468. doi: 10.1016/j.hoc.2017.01.005. Epub 2017 Mar 22.

    PubMed 28501087

  • Al-Batran SE, Homann N, Pauligk C, Illerhaus G, Martens UM, Stoehlmacher J, Schmalenberg H, Luley KB, Prasnikar N, Egger M, Probst S, Messmann H, Moehler M, Fischbach W, Hartmann JT, Mayer F, Hoffkes HG, Koenigsmann M, Arnold D, Kraus TW, Grimm K, Berkhoff S, Post S, Jager E, Bechstein W, Ronellenfitsch U, Monig S, Hofheinz RD. Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial. JAMA Oncol. 2017 Sep 1;3(9):1237-1244. doi: 10.1001/jamaoncol.2017.0515.

    PubMed 28448662

  • Li J, Yan LL, Zhang HK, Wang Y, Xu SN, Chen XJ, Qu JR. Application of intravoxel incoherent motion diffusion-weighted imaging for preoperative knowledge of lymphovascular invasion in gastric cancer: a prospective study. Abdom Radiol (NY). 2023 Jul;48(7):2207-2218. doi: 10.1007/s00261-023-03920-2. Epub 2023 Apr 21.

    PubMed 37085731

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer Stage and CT, run by Henan Cancer Hospital 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 3 inclusion and 4 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 1 Apr 2020. 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 Jinrong Qu (0371-65587595, qjryq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MSCT and MRI staging in Gastric Cancer. (time frame: up to 2 year). 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 NCT04028375, which also lists 8 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 1 Apr 2020.

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