IMaging PAtients for Cancer Drug selecTion - Renal Cell Carcinoma (IMPACT-RCC)

NCT02228954 | Completed

• 1 other identifier: IMPACT-RCC study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Rationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. By now, the investigators are not able to identify those patients with indolent disease and the minor group of patients with rapidly progressive disease. In patients with indolent disease, a watchful waiting period is preferred, since their quality of life will not be unnecessary hampered by adverse events and therapy resistance is not induced. This study aims to identify those patients for whom a watchful waiting period is possible by molecular imaging. Furthermore several types of systemic therapy are possible once the progression is proven. These systemic treatments are comparable in terms of efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary objective, the usefulness of a decision aid guiding the choice of the patients is studied. Objectives. To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:

1. 1.FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.
2. 2.FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.

Conditions

Clear-cell Metastatic Renal Cell Carcinoma; Kidney Neoplasms

Keywords

Clear-cell metastatic renal cell carcinoma; Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Time to progression

  To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of: 1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting. 2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.

  1-5 years (End of study)

Secondary Outcomes (1)

• Patient and physician questionnaires on the added value of the decision aid

  1-5 years (End of study)

Study Arms (1)

Renal Cell Cancer

Procedure: Molecular imaging

Interventions

Molecular imaging PROCEDURE

Renal Cell Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with good or intermediate prognosis mccRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent

You may qualify if:

• Histological or cytological documented mRCC with a clear cell component
• Good or intermediate prognosis, defined as none (good risk) or 1-2 intermediate risk) of the below mentioned risk factors:
• Karnofsky performance \<80
• Time from diagnosis detection of metastases \< 1 year
• Haemoglobin \< lower limit of normal (LLN)
• Corrected calcium \> upper limit of normal (ULN)
• Neutrophils \> ULN
• Platelets \> ULN
• A watchful waiting period for 2 months is considered an option according to treating medical oncologist
• No prior systemic treatment for RCC (also non-adjuvant)
• Time from diagnosis of metastases \< 3 months
• Able to provide written informed consent
• Age ≥ 18 years

You may not qualify if:

• Untreated central nervous system metastases, or symptomatic intracerebral metastases.
• Pregnant or breast feeding women.
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedure.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (3)

VU University Medical Center

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Radboudumc

Nijmegen, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma; Kidney Neoplasms

Interventions

Molecular Imaging

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Molecular Probe Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 29, 2014
• Study Start: December 1, 2014
• Primary Completion: March 5, 2018
• Study Completion: October 19, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

NL (3)