Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06454955

Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors

Led by Peking University Cancer Hospital & Institute · Updated on 2024-08-23

50

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Based on \[68Ga\]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of \[68Ga\]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.

CONDITIONS

Official Title

Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, male or female
  • White blood cell count at least 4.0 x 10^9/L or neutrophils at least 1.5 x 10^9/L
  • Platelets at least 100 x 10^9/L
  • Hemoglobin at least 90 g/L
  • Prothrombin time or activated partial thromboplastin time no more than 1.5 times the upper normal limit
  • Total bilirubin no more than 1.5 times the upper threshold limit
  • ALT and AST no more than 2.5 times the upper normal limit or no more than 5 times for those with liver metastasis
  • Alkaline phosphatase no more than 2.5 times the upper normal limit or no more than 4.5 times in cases of bone or liver metastasis
  • Blood urea nitrogen no more than 1.5 times the upper threshold limit
  • Serum creatinine no more than 1.5 times the upper threshold limit
  • Normal cardiac function
  • Expected survival of at least 12 weeks
  • Good adherence to follow-up
  • At least one measurable target lesion according to RECIST 1.1 criteria
  • Women of childbearing age (15-49 years) must have a negative pregnancy test within seven days before starting the study
  • Sexually active male and female participants must agree to use effective contraception during the study and for three months after the last examination
  • Clinical recommendation for PET/CT scans for tumor diagnosis and staging
  • Ability to understand and voluntarily agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Severe abnormalities in liver and kidney function and blood counts
  • Planning to conceive
  • Pregnant or breastfeeding women
  • Unable to lie flat for thirty minutes
  • Refusal to participate in the clinical study
  • Claustrophobia or other psychiatric disorders
  • Other conditions deemed unsuitable for trial participation by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xiangxi Meng

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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