NCT06519760

Brief Summary

The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress73%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

July 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

July 17, 2024

Last Update Submit

November 5, 2024

Conditions

Carbonic Anhydrase IXPET-CTClear Cell Renal Cell Carcinoma

Keywords

Carbonic Anhydrase IX68Ga-C1PET-CTClear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma

    Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT

    1 year

  • The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors

    Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.

    1 year

Secondary Outcomes (3)

  • The dosimetry of 68Ga-C1

    1 year

  • Quantitative evaluation of 68Ga-C1

    1 year

  • Correlation with pathological expression

    1 year

Study Arms (1)

68Ga-C1

EXPERIMENTAL

Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.

Drug: 68Ga-C1

Interventions

68Ga-C1DRUG

68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg

Also known as: CAIX specific PET imaging
68Ga-C1

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent；
  • Age ≥18；
  • Patients with confirmed or suspected clear cell renal cell carcinoma;
  • Expected survival ≥6 months.

You may not qualify if:

  • Renal mass is known to be a metastasis of another primary tumor;
  • Have other malignancies that require treatment;
  • Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
  • Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
  • Pregnant and lactating women or female patients plan to become pregnant within 6 months;
  • Uncontrolled psychiatric disorders;
  • Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

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 Diseases

Study Officials

  • Kan Gong

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kan Gong

CONTACT

(86)-010-83572075kan.gong@bjmu.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
Surgeon

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 25, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations

CN(1)