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A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiation Dosimetry and Preliminary Diagnostic Performance of 68Ga-TPP-FAPI in Patients with Malignant Tumours

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiation Dosimetry and Preliminary Diagnostic Performance of 68Ga-TPP-FAPI in Patients with Malignant Tumours

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128832
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-08-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

malignant tumour

Interventions

Intervention Group:During days 1 to 5, PET/CT scans with 68Ga-TPP-FAPI and 68Ga-FAPI-04 were performed one after the other. The order of administration is determined randomly (there should be at least

Sponsors

Tianjin Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years, inclusive. 2.Able and willing to provide written informed consent by signing the Informed Consent Form (ICF) prior to any study-specific procedures. 3.Histologically or cytologically confirmed malignant tumour; or a suspected malignant tumour based on imaging findings or clinical assessment, with planned tumour resection or biopsy within 60 days after enrolment. Patients must agree to provide an adequate formalin-fixed, paraffin-embedded (FFPE) tumour tissue sample following surgery for pathological analysis at the study centre. 4.Presence of at least one measurable lesion as defined according to RECIST version 1.1.

Exclusion criteria

Exclusion criteria: 1.Presence of another confirmed malignancy. 2.Uncontrolled severe infection or other serious concomitant disease. 3.Life expectancy of =3 months; 4.Pregnant or breastfeeding patients, or patients of childbearing potential who are unwilling to use adequate contraception during the study. 5.Patients considered by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Adverse Event and Serious Adverse Event;PET imaging characteristics;Biological distribution characteristics of important organs;

Countries

China

Contacts

Public ContactDai Dong

Tianjin Cancer Hospital

xiandao5502@163.com+86 22 2334 0123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026