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Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging (REMISCAN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00842790
First received: February 11, 2009
Last updated: April 11, 2014
Last verified: February 2009
  Purpose

The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.

The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.

Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.


Condition
Carcinoma, Renal Cell

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • RECIST criteria evolution [ Time Frame: at day 7 and after every 6 at 16 weeks during 2 years ] [ Designated as safety issue: No ]
    time-to-progression with anti-angiogenic traitment evaluated by RECIST criteria


Secondary Outcome Measures:
  • Validation of the technical and acquisition measurement models [ Time Frame: at day 7 and after every 6 at 16 weeks during 2 years ] [ Designated as safety issue: No ]
    Validation of the technical and acquisition measurement models of tumor perfusion MRI and CT, and diffusion MRI, study of reproducibility

  • Assessment of potential drug costs [ Time Frame: at the end ] [ Designated as safety issue: No ]
    Assessment of potential drug costs avoided by use of innovative prognostic criteria for adapting treatment


Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

oncologic hospital visit

Criteria

Inclusion Criteria:

  • with metastatic RCC
  • without previous recent antiangiogenic treatment

Exclusion Criteria:

  • severe renal insufficiency
  • allergy to contrast agents
  • pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842790

Locations
France
service of oncology- HEGP
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Stephane OUDART, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00842790     History of Changes
Other Study ID Numbers: P060407
Study First Received: February 11, 2009
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Carcinoma, Renal Cell [C04.557.470.200.025.390]
Angiogenesis Inhibitors [D27.505.954.248.025]
Tomography Scanners, X-Ray Computed [E07.913]
Magnetic Resonance Imaging [E01.370.350.825.500]
Diffusion Magnetic Resonance Imaging [E01.370.350.825.500.150]
Perfusion [E05.680]

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014