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NCT07552467: LRRC15 PET Imaging for GI Tumor Diagnosis Study

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Summary

NIH ClinicalTrials.gov has registered an observational study (NCT07552467) evaluating LRRC15-specific PET radiotracers as targeted imaging agents for diagnosis and staging across eight malignant tumor types: pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study will enroll both patients and healthy volunteers, comparing LRRC15 PET imaging against histopathological diagnosis and against existing agents [18F]FDG PET and [68Ga]Ga-FAPI PET to evaluate diagnostic efficacy and facilitate therapeutic decision-making.

“By comparing the imaging results against the gold standard of histopathological diagnosis, the study aims to evaluate diagnostic efficacy, ascertain the presence or absence of lesions, and characterize their anatomical location and nature.”

NIH/NLM , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

NIH ClinicalTrials.gov registered a new observational study (NCT07552467) titled 'Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors.' The study will use LRRC15-specific PET radiotracers with PET/MR or PET/CT imaging in healthy volunteers and patients with eight specified cancer types characterized by high LRRC15 expression. For patients, the study aims to diagnose and stage disease by comparing imaging results against histopathological diagnosis as the gold standard, and to compare LRRC15 PET against existing [18F]FDG PET and [68Ga]Ga-FAPI PET for disease staging, tumor burden assessment, and therapeutic decision-making. For healthy volunteers, the study will evaluate radiotracer biodistribution, metabolic patterns, and safety profile.\n\nSponsors and clinical investigators conducting or planning oncology imaging trials should be aware of this emerging LRRC15-targeted PET modality as a potential competitor or complement to existing metabolic and FAP-targeted imaging approaches. The registry entry itself does not impose compliance obligations but signals active clinical development of this novel radiopharmaceutical for precision diagnostics in multiple solid tumor indications.

Archived snapshot

Apr 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Sub-topic Four: Clinical Translation of Original Radioactive Drugs for Precision Diagnosis and Treatment of Gastrointestinal Tumors -Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors

Observational NCT07552467 Kind: OBSERVATIONAL Apr 27, 2026

Abstract

This project utilizes LRRC15-specific targeted PET radiotracers to perform PET/MR or PET/CT imaging on healthy volunteers and patients with clinically suspected or confirmed malignancies characterized by high LRRC15 expression-including pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study aims to achieve the following objectives:

For patients with malignant tumors: To diagnose and stage the disease. By comparing the imaging results against the gold standard of histopathological diagnosis, the study aims to evaluate diagnostic efficacy, ascertain the presence or absence of lesions, and characterize their anatomical location and nature. Furthermore, through comparison with [¹⁸F]FDG PET or [⁶⁸Ga]Ga-FAPI PET, the study seeks to achieve accurate disease staging, assess tumor burden, and facilitate therapeutic decision-making.

For healthy volunteers: To conduct pharmacokinetic analyses to determine the in vivo biodistribution and metabolic patterns of the radiotracer, as well as to evaluate its safety profile.

Conditions: Pancreatic Cancer, Breast Cancer, Lung Cancer, Sarcoma, Head and Neck Tumors, Glioblastoma, Colorectal Cancer, Melanoma

Interventions: Specific PET imaging agents targeting LRRC15

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Last updated

Classification

Agency
NIH/NLM
Published
April 27th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Patients Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Diagnostic imaging Clinical trial registration Cancer staging
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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