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)
  Hide Detailed Description

Detailed Description:

The aim is to evaluate the capacity of functional CT and functional MRI to measure reliable biomarkers capable of evaluating the efficacy of anti-angiogenic treatment.

Patient and methods

- Patients 200 patients with metastatic RCC will be enrolled in the study. Patients will be recruited by an oncologist and the images will be acquired by a radiologist.

Patients will be followed until tumor progression (as defined by RECIST) or during 2 years following inclusion if there is no progression.

- Imaging data acquisition Morphological and functional imaging will be obtained before the beginning of the anti-angiogenic treatment, at 7±2 days and every 6 weeks until tumor progression.

Progression is defined following the RECIST criteria.

  • CT examination will be have two parts: the first one will be a dynamic acquisition during 3 min (using low kV)focused on a "functional target lesion" during bolus injection of a contrast agent for functional analysis, and the second one will be a morphologic acquisition over the chest, the abdomen and the pelvis for RECIST evaluation.
  • MRI examination will have two parts: the first one will be a diffusion weighted sequence focused on the same functional target as the one imaged on CT, and the second one will be a dynamic acquisition using a T1 weighted gradient echo sequence with less than 4 s sampling time during 5min following the bolus injection of contrast agent.

    • Imaging data analysis The examinations will be anonymized and transferred to a workstation for processing. Images will be processed by two independent readers.

Diffusion coefficient maps will be obtained using linear regression. The microvascular parametric maps yielding as tissue blood flow, tissue blood volume, mean transit time, permeability surface area product and tissue interstitial volume will be calculated for both the CT and MRI dynamic series using a proprietary software by means of compartmental modeling with an arterial input function (AIF).

Mean parameters will be recorded for different regions of interest (ROI) in the tumors (whole tumor, periphery, center).

Morphological CT images will be analyzed following the RECIST criteria.

-Statistical analysis The functional parameters will be analyzed for inter-observer reproducibility. The correlation between parameters obtained using functional CT and functional MRI will tested.

Patients will be classified as good responders and poor responders according to RECIST follow-up.

The correlation between each baseline functional parameter and the RECIST response will be tested to evaluate the usefulness of the baseline parameters as predictors of response.

The correlation between each parameter's changes under treatment as compared to the baseline value will be tested to evaluate the efficacy of each parameter to detect the response to the anti-angiogenic drug. The precocity of the detection of the response using the parameter variations will be also tested.

Finally, the economical impact of the use of the microvascular parameters as biomarkers of treatment efficacy will be tested.

  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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014