NCT07557225

Brief Summary

The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Mar 2029

Study Start

First participant enrolled

April 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 22, 2026

Last Update Submit

April 28, 2026

Conditions

Urothelial Carcinoma (UC)Ovarian CancerHead and Neck CancerEndometrial CancerClear Cell Renal Cell Cancer (ccRCC)Von Hippel Lindau DiseaseColorectal CancerCervical CancerHepatocellular Carcinoma (HCC)CholangiocarcinomaNon Small Cell Lung CancerSmall Cell Lung CancerBreast CancerPancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors

    The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard.

    From study completion to 1 month after completion

  • Incidence of Adverse Events [Safety and Tolerability]

    Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).

    24 hours after the injection of 18F-T2

Secondary Outcomes (4)

  • Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT

    From study completion to 1 month after completion

  • Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT

    From study completion to 1 month after completion

  • Correlation between T2 Uptake and CAIX Pathological Expression

    From study completion to 1 month after completion

  • Dosimetry of 18F-T2

    From study completion to 1 month after completion

Study Arms (1)

18F-T2 PET/CT

EXPERIMENTAL

Participants with tumors likely to express high levels of CAIX will receive an intravenous injection of 18F-T2 followed by PET/CT imaging. The participants will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.

Diagnostic Test: 18F-T2 PET/CT

Interventions

18F-T2 PET/CTDIAGNOSTIC_TEST

18F-T2 is injected intravenously with a dose of 0.05-0.10 mCi/kg. The CT and PET imaging session will begin approximately 60 minutes after 18F-T2 administration.

18F-T2 PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants must meet the following criteria:
  • Written and voluntarily given Informed Consent.
  • Male or female ≥18 years of age at time of consent.
  • Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
  • Participants with histologically confirmed or suspected tumors of the following types, but not limited to:
  • Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.

You may not qualify if:

  • Participants will be excluded from participation in the study if one or more of the following criteria are met:
  • Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
  • Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
  • Be a female who is pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Carcinoma, Renal CellCarcinoma, Transitional CellColorectal NeoplasmsUterine Cervical NeoplasmsOvarian NeoplasmsHead and Neck NeoplasmsCarcinoma, HepatocellularCholangiocarcinomaCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaBreast NeoplasmsPancreatic NeoplasmsEndometrial Neoplasmsvon Hippel-Lindau Disease

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersLiver NeoplasmsLiver DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPancreatic DiseasesNeurocutaneous SyndromesNervous System DiseasesAngiomatosisVascular DiseasesCardiovascular DiseasesCiliopathiesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Meng Liu

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keting Tong

CONTACT

+86 010-835752521910301229@pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 29, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

CN(1)