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A single-arm, open-label, single-center clinical study to the evaluation of integrin avß6-targeted positron emission tomography (PET) for malignant tumors

A single-arm, open-label, single-center clinical study to the evaluation of integrin avß6-targeted positron emission tomography (PET) for malignant tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066067
Enrollment
Unknown
Registered
2022-11-23
Start date
2022-11-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Malignant tumor

Interventions

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The subject voluntarily participates in the trial and signs the informed consent form; (2) Age = 18 years old and = 80 years old (subject to the date of signing the informed consent form), gender is not limited; (3) Patients with malignant solid tumors with high suspicion of imaging or histological/cytology confirmed by histological/cytology, and patients who are going to undergo surgery; (4) The physical status score (ECOGPS) of the Eastern Cancer Cooperative Group was 0-1 points; (5) Estimated survival time = 6 months; (6) Female subjects of childbearing age, male subjects, and partners of male subjects agree to use reliable contraceptive measures (e.g., abstinence, sterilization, birth control pills, injectable contraceptives methylprogesterone, or subcutaneous contraception) for 6 months after the end of the last study drug infusion.

Exclusion criteria

Exclusion criteria: (1) Known allergy to injection or its excipients; (2) Those who have received any investigational drug or device clinical trial within 30 days (or 5 half-lives of the drug, whichever is longer) before signing the ICF; (3) Female patients who plan to become pregnant within 6 months, or are pregnant or breastfeeding; (4) claustrophobia; (5) Those who cannot tolerate raising their arms and lying flat for 15~30min; (6) Other circumstances that the investigator believes should be excluded and documented.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;positive predictive value;negative predictive value;

Secondary

MeasureTime frame
Maximum Standard Uptake Value;Mean Standard Uptake Value;Maximum tumor-to-background ratio;Mean tumor-to-background ratio,TBR;total lesion uptake,TLU;

Countries

China

Contacts

Public ContactHe Yong

Zhongnan Hospital of Wuhan University

vincentheyong@163.com15527981006

Outcome results

None listed

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