ClinicalTrials.gov
ClinicalTrials.gov Menu

Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03616951
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Frede Donskov, University of Aarhus

Brief Summary:

The incidence of renal cancer in Denmark is approximately 900 new cases per year. Untreated, the 5-year survival rate for metastatic renal cancer (mRCC) is 2%. Development of angiogenesis inhibitors (AI) and check-point immunotherapy (CPI) has improved survival.

Treatment efficacy is evaluated by CT scans, using RESIST 1.1 (Response Evaluation Criteria in Solid Tumors). However, progressin in patients with mRCC treated with AI or CPI is difficult to characterize at the right time, using the RECIST 1.1. Therefore approximately 50 % of the patients are 'lost' to further treatment at the time of progression and die.

The investigators aim to evaluate if functional imaging parameters using spectral CT-techniques can detect treatment failure earlier, or more accurate, than routine CT. This could help us develop a new set of response evaluation criteria for functional imaging, giving a more precise assessment of treatment effect in patients with mRCC treated with AI and CPI.


Condition or disease
Renal Neoplasm With Metastasis Response Evaluation Criteria in Solid Tumors

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Response Evaluation Criteria in Metastatic Renal Cell Carcinoma: Improved Assessment of Response and Progression by Spectral-CT
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: PFS is the time from the initiation of therapy and until progressive disease or death, whichever comes first - assessed up to 60 months. If a patient does not progress, PFS will be censored at the time of last follow-up - assessed up to 60 months. ]
    PFS is the time from the initiation of therapy and until progressive disease or death, whichever comes first, assessed up to 60 months. If a patient does not progress, PFS will be censored at the time of last follow-up - assessed up to 60 months.

  2. overall survival [ Time Frame: Overall survival is the time between the first day of treatment and the date of death or last follow-up - assessed up to 60 months. ]
    Overall survival is the time between the first day of treatment and the date of death or last follow-up - assessed up to 60 months.


Secondary Outcome Measures :
  1. Best response [ Time Frame: Time from inclusion to best response - assessed up to 60 months. ]
    Response will be categorized according to the criteria from RECIST 1.1: complete response, partial response, stable disease and progressive disease - assessed up to 60 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with metastatic renal cell carcinoma, who are going to be treated with immunotherapy og angiogenesis inhibitors.
Criteria

Inclusion Criteria:

  1. Minimum 18 years
  2. Metastatic renal cell carcinoma
  3. Oncologic treatment with immunotherapy or angiogenesis inhibitors
  4. The patients have signed an informed consent statement
  5. Can cooperate for the examinations

Exclusion Criteria:

  1. Glomerular filtration fraction below 35 ml/min
  2. Allergies or other contraindications to the use of contrast media

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616951


Contacts
Contact: Frede Donskov, MD, DMSc, associate professor + 45 40465234 frede.donskov@auh.rm.dk
Contact: Aska Drljevic-Nielsen, MD, ph.d-student +45 28490381 askadrlj@rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000/8200
Contact: aska drljevic-nielsen, MD, ph.d-student    28490381    askadrlj@rm.dk   
Principal Investigator: Frede Donskov, MD, DMSc, Associate Professor         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Frede Donskov, MD, DMSc Department of oncology, Aarhus Universety Hospital

Responsible Party: Frede Donskov, Consultant, Associate Professor, University of Aarhus
ClinicalTrials.gov Identifier: NCT03616951     History of Changes
Other Study ID Numbers: 151115
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases