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Not yet recruiting NCT07671417

Imaging Study in Metastatic Clear Cell RCC.

Early Phase I Interventional Metastatic Clear Cell Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RYZ512.
Who it may be relevant to
Registry conditions: Metastatic Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).

Overview

This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).

Interventions

  • Diagnostic test RYZ512
    Imaging Agent

Primary outcome measures

  • To assess the tolerability of the imaging agent subjects with metastatic clear cell RCC. [Time frame: Study duration (6 months)]
  • To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC. [Time frame: Study duration (6 months)]
  • To evaluate the radiation absorbed doses of RYZ512 in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC. [Time frame: Study duration (6 months)]

Eligibility criteria

Inclusion criteria

  • At least 18 years old at the time of signing the informed consent form (ICF).
  • Biopsy proven metastatic clear cell renal cell carcinoma (RCC)

Exclusion criteria

  • Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides
  • Women of Childbearing Potential that are pregnant or breastfeeding.

Note: Additional criteria may apply and will be assessed by the study site

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

New Zealand · 1 center
  • Research Facility — Christchurch

Identifiers

NCT: NCT07671417 · RYZ512-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗