NCT05140746

Brief Summary

This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
16mo left

Started Sep 2020

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Sep 2020Sep 2027

Study Start

First participant enrolled

September 10, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2027

Expected
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

November 8, 2021

Last Update Submit

January 8, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

  • Prediction for NAC efficacy

    Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.

    Two weeks after surgery

  • Standardized uptake value(SUV)

    SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.

    Two weeks after surgery

  • Target-to-background ratio(TBR)

    68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.

    Two weeks after surgery

Secondary Outcomes (3)

  • Diagnostic efficacy for metastatic lymph nodes

    Two weeks after surgery

  • Disease free survival

    5 years

  • Overall survival

    5 years

Study Arms (1)

PET/CT for prediction of NAC efficacy

EXPERIMENTAL

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.

Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

Interventions

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CTDIAGNOSTIC_TEST

Baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans before NAC followed by abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans after one cycle of NAC treatment or before surgery.

PET/CT for prediction of NAC efficacy

Eligibility Criteria

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

You may qualify if:

  • Age between 18-75 years.
  • Histologically confirmed gastric adenocarcinoma through gastroscopy.
  • Resectable gastric cancer.
  • ECOG performance status 0-1.
  • White blood count \>4x109/L, Absolute neutrophil count (ANC) \>2x109/L, Hemoglobin (Hb)\>90g/L, Platelets \>100x109/L.
  • Ejection Fraction\>50%.
  • Serum bilirubin \<1.5x ULN; ALT and AST \<1.5x ULN.
  • Serum creatinine ≤1.5x ULN, or GFR\> 60ml/min.
  • Agreement to participate in this study with informed consent form.
  • Willingness and ability to comply with the protocol for the duration of the study.
  • No children bearing petential in the next six months before enrollment.

You may not qualify if:

  • With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
  • Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
  • With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
  • With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
  • With severe mental symptoms, unconscious or unable to complete the examination.
  • Pregnancy or possibly pregnant woman, breastfeeding woman.
  • Lack of compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Miao Y, Feng R, Yu T, Guo R, Zhang M, Wang Y, Hai W, Shangguan C, Zhu Z, Li B. Value of 68Ga-FAPI-04 and 18F-FDG PET/CT in Early Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer. J Nucl Med. 2024 Feb 1;65(2):213-220. doi: 10.2967/jnumed.123.266403.

    PMID: 38164574DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Zhenggang Zhu

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Miao

CONTACT

0086-13671921521myada821@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 1, 2021

Study Start

September 10, 2020

Primary Completion

September 10, 2024

Study Completion (Estimated)

September 10, 2027

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations

CN(1)