Biodistribution and radiation dosimetry of a novel gallium-68 radiopharmaceutical for positron emission tomography of cell death in patients with solid malignancies.

Not Applicable

Completed

• Conditions: Cancer; Cancer - Any cancer

• Registration Number: ACTRN12621000641897
• Lead Sponsor: Prince of Wales Hospital

Brief Summary

This study assesses human biodistribution, radiation dosimetry, safety and tumour uptake of cell death indicator labelled with 68Ga ([68Ga]Ga-CDI), a novel radiopharmaceutical that can image multiple forms of cell death. Five participants with at least one extracranial site of solid malignancy>2 cm and no active cancer treatment in the 8 weeks prior to the study were enrolled. [68Ga] Ga-CDI is safe and well-tolerated with no side effects or adverse events observed. [68Ga]Ga-CDI is renally excreted, demonstrates low levels of physiologic uptake in the other organs and has excellent imaging characteristics. The mean effective dose was 2.17E- 02± 4.61E-03 mSv/MBq. It images constitutive tumour cell death and correlates with tumour cell death on histology. In summary, [68Ga]Ga-CDI is a novel cell death imaging radiopharmaceutical that is safe, has low radiation dosimetry and excellent biodistribution and imaging characteristics. It has potential advantages over previously investigated radiopharmaceuticals for imaging of cell death and has progressed to a proof-of-concept trial.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-23
• Study Start: 2021-05-28
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Patients must be able to understand and willing to sign the written informed consent
Male or female patients greater than or equal to 18 years of age
Histologically or cytologically confirmed solid malignancy with at least one measurable lesion greater than 2 cm
Adequate liver function (bilirubin less than or equal to 1.5 upper limit normal (ULN), ALT and AST less than or equal to 4 ULN)
Adequate renal function (eGFR greater than less than or equal to 50 ml/min/1.73m2)
Adequate bone marrow function (absolute neutrophil count greater than or equal to 1.5 x 10^9/l, haemoglobin level greater than or equal to 9.0 g/dl and platelets greater than or equal to 100 ×x 10^9/l).
Serum potassium greater than or equal to 3.0mmol/l and magnesium greater than or equal to 0.6mmol/l

Exclusion Criteria

Cancer treatment within the previous 6 weeks
Primary or isolated metastatic CNS malignancy
Active uncontrolled infection
Congestive heart failure or prior NYHA class III-IV cardiac disease
Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP >100mmHg)
Evidence of recent heart disease (myocardial infarction in the past 2 months by ECG, arrhythmias associated with QTc prolongation or evidence of ischemia)
Evidence of QTc > 480 ms
Medications that prolong QTc
Pregnancy
Breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified