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Prospective study on the value of 18F-FDG-PET/MR in predicting the pathological response and lymph node metastasis of patients with esophageal squamous cell carcinoma after neoadjuvant immunochemotherapy

Prospective study on the value of 18F-FDG-PET/MR in predicting the pathological response and lymph node metastasis of patients with esophageal squamous cell carcinoma after neoadjuvant immunochemotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080175
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cell carcinoma

Interventions

18F-FDG-PET/MR group:None

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Potential resectable esophageal squamous cell carcinoma patients (clinical TNM stage II-IIIexcluding adenosquamous carcinoma mixed type and other pathological types). 2. The score of ECOG or PS is 0 or 1. 3. Patients received neoadjuvant therapy of PD-1 inhibitor combined with chemotherapy. 4. The patients had whole body PET/CT and/or esophageal PET/MR examinations to determine the stage and exclude distant metastasis. 5. The patients have complete clinical and pathological data.

Exclusion criteria

Exclusion criteria: 1. Cervical esophageal cancer and gastroesophageal junction tumor confirmed by endoscopy. 2. Lack of PET CT and esophageal PRT/MR examination results before treatment and surgery. 3. Lack of biopsy pathology to confirm esophageal squamous cell carcinoma. 4. Have received other treatments except immunity and chemotherapy, such as radiotherapy, targeted therapy. 5. Patients with renal insufficiency, contraindication of magnetic resonance imaging, and severe allergic reaction to the Gadolinium contrast agent. 6. The following patients who are not suitable for magnetic resonance imaging (MRI), including cardiac pacemakers, metal artificial valves, intracranial and mediastinal vascular clips, cardiac defibrillators, nerve stimulators, implanted drug delivery systems, intraocular metal foreign bodies, cochlear implants, metal fragments of dangerous body parts within 8 weeks, Swan Ganz catheters and other metal implants: such as heart valves, stents, coils, filters and clips. 7. Patients with claustrophobia. 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Area Under Curve;

Secondary

MeasureTime frame
sensitivity;specificity;positive preditive value;negative preditive value;accuracy;

Countries

China

Contacts

Public ContactChao Cheng

The First Affiliated Hospital of Sun Yat-sen University

chengch3@mail.sysu.edu.cn+86 137 1076 3975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026