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Clinical Trial NCT06688305 for Malignant Neoplasm is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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68Ga-NI-FAPI PET/CT: First-in-human Study Early Phase 1 40 First-in-Human Novel Treatment

Recruiting
Clinical Trial NCT06688305 is designed to study Diagnostic for Malignant Neoplasm. It is a Early Phase 1 interventional study that is recruiting, having started on 1 August 2024, with plans to enroll 40 participants. Led by First Affiliated Hospital of Fujian Medical University, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 14 November 2024.
Brief Summary
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
Detailed Description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such...Show More
Official Title

68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers

Conditions
Malignant Neoplasm
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • FirstAHFujian-68Ga-NI-FAPI
NCT ID Number
NCT06688305
Start Date (Actual)
2024-08-01
Last Update Posted
2024-11-14
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental68Ga-NI-FAPI PET/CT
PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.
68Ga-NI-FAPI
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
safety and tolerability
Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
up to 1 week
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dosimetry of normal organs and tumors
The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 68Ga-NI-FAPI. The dose delivered to normal organs and tumors will be recorded.
From right after tracer injection to 150 minutes at post-injection
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Various solid tumors with available histopathological findings
  • Signed informed consent

  • pregnant or lactational women
  • who suffered from severe hepatic and renal insufficiency
First Affiliated Hospital of Fujian Medical University logoFirst Affiliated Hospital of Fujian Medical University
Study Central Contact
Contact: Weibing Miao, MD, +86-0591-87981618, [email protected]
Contact: Jie Zang, MD, +86-0591-87981619, [email protected]
1 Study Locations in 1 Countries

Fujian

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China
Jie Zang, PhD, MD, Contact, 86-0591-87981619, [email protected]
Weibing Miao, MD, Contact, MD 86-0591-87981618, [email protected]
Recruiting