Clinical Applications of FAPI PET in Solid Tumors

NCT07776899 | Recruiting

• 1 other identifier: 2026 CER 311
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET

  Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.

  Through study completion, an average of 3 years

• AUC of FAPI-RuiJ PET versus FAPI-04 PET

  Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.

  Through study completion, an average of 3 years

Secondary Outcomes (4)

• Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions

  At the time of PET/CT scan

• Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions

  At the time of PET/CT scan

• Biodistribution characteristics of FAPI-RuiJ PET in normal organs

  At the time of PET/CT scan

• Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors

  Through study completion, an average of 3 years

Study Arms (2)

Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day

EXPERIMENTAL

Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-RuiJ administered first and FAPI-04 on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard.

Diagnostic Test: FAPI-RuiJ; Diagnostic Test: FAPI-04

Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day

EXPERIMENTAL

Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-04 administered first and FAPI-RuiJ on a separate day (interval: 1-7 days). For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time. All images will be independently reviewed by two blinded nuclear medicine physicians. Histopathology or imaging follow-up serves as the reference standard.

Diagnostic Test: FAPI-RuiJ; Diagnostic Test: FAPI-04

Interventions

FAPI-RuiJ DIAGNOSTIC_TEST

A novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.

Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day; Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day

FAPI-04 DIAGNOSTIC_TEST

A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.

Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day; Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 80 years, regardless of gender.
• Participants with suspected, confirmed, or suspected recurrent solid tumors.
• Participants who agree to participate in this clinical trial and provide written informed consent.
• Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.
• No plans for pregnancy within 6 months.

You may not qualify if:

• Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.
• Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.
• Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.
• Pregnant or breastfeeding women.
• Patients with poor compliance.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Study Officials

• Biao Li

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Miao

CONTACT

0086-13671921521; myada821@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 20, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-04

Locations

CN (1)