89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE

NCT03556046 | Completed Phase 1

• 1 other identifier: TLX-89Zr-TX-250-001D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.

Conditions

Clear Cell Renal Carcinoma

Keywords

Clear Cell Renal Carcinoma

Outcome Measures

Primary Outcomes (5)

• Safety parameter Physical Examination

  Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.

  8 days

• Safety parameter Vital Signs

  Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs including the 12-lead ECG.

  8 days

• Safety parameter Adverse Events

  Frequency of occurrence and severity of abnormal findings in safety investigations regarding Adverse Events.

  8 days

• Safety parameter Laboratory examinations

  Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.

  8 days

• Safety parameter concomitant medications

  Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.

  8 days

Secondary Outcomes (5)

• Radiation dosimetry

  Whole body (neck to mid-thigh) static PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT without contrast agent.

• Diagnostic efficacy

  PET image acquisitions will be obtained in list mode on a TOF-capable machine for a period of 20 minutes.

• Tumour dosimetry Absorbed dose

  PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.

• Tumour dosimetry Activity

  PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.

• Tumour dosimetry absorbed Dose

  PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.

Study Arms (1)

89Zr-girentuximab

EXPERIMENTAL

A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 5 mg of girentuximab

Diagnostic Test: 89Zr-Girentuximab

Interventions

89Zr-Girentuximab DIAGNOSTIC_TEST

Single diagnostic injection on Day 0, followed by diagnostic scans on Days 3 and 7±1, as well as the whole body dosimetric imaging on Days 0, 1, 3 and 7±1

89Zr-girentuximab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Male or female \>50 years of age
• Clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up or patients with established diagnosis of CCRC requiring imaging for recurrent disease
• Life expectancy of at least 6 months
• Consent to practise double-barrier contraception until end of study (7 days after 89Zr-girentuximab injection)

You may not qualify if:

• Known hypersensitivity to girentuximab
• Known uncontrolled hyperthyreoidism
• Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab
• Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab.
• Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03)
• Planned (for the period between injection of 89Zr-girentuximab and imaging) antineoplastic therapies
• Established renal cell carcinomas of other histological entities than CCRC
• Known brain metastases
• Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the patient, as judged by the investigator
• Pregnant or breast-feeding women. Female patients of childbearing potential or male patients with female partners of childbearing potential, unless willing to practice full and true sexual abstinence or being surgically/permanently sterile or with a history of hysterectomy for women, not willing to practice effective double-barrier contraception by using: a non-oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, during the study period and within a period of 30 days (corresponding to 8 half-lives of 89Zr) after receiving study drug.
• Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ABX CRO: collaborator
• Telix Pharmaceuticals (Innovations) Pty Limited: collaborator

Study Sites (1)

Radboud University

Nijmegen, 6525, Netherlands

Location

Related Publications (1)

• Merkx RIJ, Lobeek D, Konijnenberg M, Jimenez-Franco LD, Kluge A, Oosterwijk E, Mulders PFA, Rijpkema M. Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3277-3285. doi: 10.1007/s00259-021-05271-w. Epub 2021 Mar 2.

  PMID: 33651116 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael Tapner

  ABX CRO

  STUDY DIRECTOR

• Peter F. A. Mulders, Prof.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 14, 2018
• Study Start: April 5, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: April 1, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)