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The value of FAPI-PET/MRI on assession of lymphatic metastasis and other prognostic factors in rectal cancer patients: a monocenter prospective clinical research

The value of FAPI-PET/MRI on assession of lymphatic metastasis and other prognostic factors in rectal cancer patients: a monocenter prospective clinical research

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069601
Enrollment
Unknown
Registered
2023-03-21
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

rectal cancer

Interventions

Gold Standard:HE staining and immunohistochemistry of pathologicaltissues and suspicious lymph nodes of patients after surgery
Index test:The accuracy (sensitivity, specificity) of FAPI-MRI in evaluating lymph node metastasis, mesorectal fascial invasion, extraintestinal vascular invasion, and immune cell infiltration in rect

Sponsors

the First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1) 18-79 years old, male or female; 2) Diagnosed with locally advanced rectal cancer (stage II/III) from January 2023 to December 2025, intending to receive neoadjuvant chemoradiotherapy and surgical treatment , accepting long-term follow-up; 3) Pelvic FAPI-PET/MRI scan and other imaging examinations are performed within 14 days before radiotherapy and chemotherapy; 4) Signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1) Patients who have received tumor treatments such as radiotherapy, chemotherapy, immunotherapy, etc. before surgery; 2) The patient has contraindications to surgery or radiotherapy, or refuses treatment; 3) Women who are trying to get pregnant, pregnant and lactating; 4) Patients suffering from claustrophobia or other psychiatric disorders; 5) Patients with other malignant tumors or distant metastases; 6) Other cases in which the investigator deems it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Accuracy of FAPI-PET/MRI for the evaluation of lymph node metastasis;

Secondary

MeasureTime frame
Accuracy of FAPI-PET/MRI for the evaluation of invasion of the mesenteric fascia;Accuracy of FAPI-PET/MRI for the evaluation of invasion of the extramural vasculature;Feasibility of FAPI-PET/MRI for the assessment of immune cell infiltration in tumor tissue;

Countries

China

Contacts

Public ContactZhao Feng

the First Affiliated Hospital of Zhejiang University School of Medicine

zju_zhaofeng@zju.edu.cn+86 15888851630

Outcome results

None listed

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