Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer Patients Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

Evaluate the safety of 18F-LNC1007 injection
The safety assessments of this phase I trial are based on systemic safety evaluation. The frequency and severity of Treatment emergent adverse events (TEAE) will be classified according to Common Toxicity Criteria for Adverse Events 5.0. The seriousness and relationship of study treatment will be assessed.
Through study completion, assessed up to 2 years

Secondary Outcomes (6)

Evaluate the radioactivity of 18F-LNC1007 injection
Through study completion, assessed up to 2 years
Evaluate the metabolites of 18F-LNC1007 injection
Through study completion, assessed up to 2 years
Evaluate total source organ counts of 18F-LNC1007 injection
Through study completion, assessed up to 2 years
Evaluate the SUV values of 18F-LNC1007 Injection
Through study completion, assessed up to 2 years
Evaluate the image quality of 18F-LNC1007 injection
Through study completion, assessed up to 2 years
+1 more secondary outcomes

Study Arms (1)

18F-LNC1007 Injection

EXPERIMENTAL

a single dose of 18F-LNC1007 Injection will be administered

Drug: 18F-LNC1007 Injection

Interventions

18F-LNC1007 InjectionDrug

Healthy volunteers will receive 1 MBq/kg and cancer patients will receive 3.7 MBq/kg. The injection will be carried out on the scan bed via an IV indwelling catheter. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.

18F-LNC1007 Injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Express willingness and ability to comply with all study procedures and restrictions.
Be healthy adult volunteers, or light tumour burden cancer patients, as defined by \<5 lesions and MITV of \<10ml on a PET/CT performed for clinical purposes. Eligibility includes adults of any gender.

Sponsors & Collaborators

Yantai LNC Biotechnology Singapore PTE. LTD.
Industrylead

Study Sites (1)

Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre)

Melbourne, Australia

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 24, 2024

Study Start

July 29, 2024

Actual (reported)

Primary Completion

You may not qualify if:

Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia and pregnancy.
A medical history of epilepsy or seizures, excluding febrile convulsions during childhood.
Blood donation or experienced major blood loss (\> 400 mL) within 3 months prior to the screening or during the study period.
For healthy volunteers: participants with a clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to:
Conditions related to circulatory, respiratory, digestive, urinary, hematological, neurological, endocrine, and musculoskeletal systems.
History of mental disorders or any other disease with clinical significance.
History of major surgery or anticipated major surgery within 1 month prior to the screening or during the study period.
For healthy volunteers: medical comorbidities that may interfere with the absorption or metabolism of the investigational drug, limit the interpretation of the trial results, and/or are deemed clinically significant by the investigator.
For healthy volunteers: abnormal findings in physical examination, vital signs, laboratory tests, or 12-lead ECG during the screening period, considered clinically significant by the investigator (Baseline physical examination, laboratory tests, and 12-lead ECG can accept results from Day -7 to Day -1).
For healthy volunteers: use of any prescription drugs, over-the-counter drugs, or traditional herbal medicine within 14 days before administration.
Active and clinically significant bacterial, fungal, or viral infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness (patients with treated HIV and hepatitis B or C could be included).
Insufficient venous access (two different venous accesses are required for the injection of the experimental drug and PK blood sampling).
Female participants who are pregnant (positive pregnancy test at screening) or lactating, or are of childbearing potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization), who do not agree to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent) and for one month after administration.
Male participants with plans for procreation or sperm donation during the trial (from the signing of the informed consent) and one month after administration or who do not wish to take effective contraceptive measures (such as complete abstinence, condom use, surgical sterilization, etc.).
Subjects with a history of allergies that the investigator believes could increase the trial risk.
+9 more criteria

Clinical Study of 18F-LNC1007 Injection PET/CT

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

18F-LNC1007 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

18F-LNC1007 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations