Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
NCT ID: NCT05140746
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-09-10
2027-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET/CT for prediction of NAC efficacy
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
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.
Interventions
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68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
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.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed gastric adenocarcinoma through gastroscopy.
3. Resectable gastric cancer.
4. ECOG performance status 0-1.
5. White blood count \>4x109/L, Absolute neutrophil count (ANC) \>2x109/L, Hemoglobin (Hb)\>90g/L, Platelets \>100x109/L.
6. Ejection Fraction\>50%.
7. Serum bilirubin \<1.5x ULN; ALT and AST \<1.5x ULN.
8. Serum creatinine ≤1.5x ULN, or GFR\> 60ml/min.
9. Agreement to participate in this study with informed consent form.
10. Willingness and ability to comply with the protocol for the duration of the study.
11. No children bearing petential in the next six months before enrollment.
Exclusion Criteria
2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
5. With severe mental symptoms, unconscious or unable to complete the examination.
6. Pregnancy or possibly pregnant woman, breastfeeding woman.
7. Lack of compliance.
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhenggang Zhu
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PET-NAC-GC
Identifier Type: -
Identifier Source: org_study_id
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