68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

NCT04831307 | Unknown

• 1 other identifier: H21-00749
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preliminary evaluation of a radiotracer's biodistribution in human subjects. It is a prospective, single-centre, open-label, single group assignment interventional study. Prostate cancer is very common, and PSMA imaging is currently the most accurate means of localizing these tumours. The goal is to evaluate the biodistribution and safety of \[68Ga\]HTK03149 PET/CT for prostate cancer imaging.

Conditions

Prostate Cancer; Prostatic Neoplasm; Prostatic Disease; Urogenital Neoplasms; Disease Attributes; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Biodistribution of 68Ga-HTK03149 PET/CT in human subjects

  Evaluate the biodistribution of 68Ga-HTK03149 in human subjects, which will enable calculating the radiation dosimetry of this radiopharmaceutical. The efficacy parameters will be the following: Individual organ dose and effective dose measured in mSV/MBq. Descriptive statistics on normal organ and tumour uptake reported in standardized uptake values (SUV). Tumour/blood, tumour/liver, tumour/kidney and tumour/lung ratios will be reported.

  Up to 12 months

Secondary Outcomes (3)

• Number of participants with 68Ga-HTK03149 related adverse events as assessed by abnormal vital sign measurement

  Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection

• Number of participants with self-reported 68Ga-HTK03149 related adverse event

  18-72 hours

• Perform a preliminary assessment of 68Ga-HTK03149 uptake in prostate cancer lesions

  Up to 12 months

Study Arms (1)

[68Ga]Ga-HTK03149 PET/CT

EXPERIMENTAL

200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT

Other: [68Ga]Ga-HTK03149 PET/CT

Interventions

[68Ga]Ga-HTK03149 PET/CT OTHER

200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT

[68Ga]Ga-HTK03149 PET/CT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with newly diagnosed or documented prostate cancers (PCa), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-DCFPyL or 68Ga-PSMA-11 PET).
• ECOG performance status of 2 or less.

You may not qualify if:

• Medically unstable (eg. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
• Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
• Patients with baseline ALT or AST higher than 5× ULN or 250 U/L.
• Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μL.
• Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Urogenital Neoplasms; Disease Attributes; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: August 30, 2021
• Primary Completion: December 1, 2021
• Study Completion: August 1, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-03

Locations

CA (1)