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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00842790
Other study ID # P060407
Secondary ID
Status Completed
Phase N/A
First received February 11, 2009
Last updated October 5, 2015
Start date September 2008
Est. completion date July 2014

Study information

Verified date February 2009
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- with metastatic RCC

- without previous recent antiangiogenic treatment

Exclusion Criteria:

- severe renal insufficiency

- allergy to contrast agents

- pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France service of oncology- HEGP Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary RECIST criteria evolution time-to-progression with anti-angiogenic traitment evaluated by RECIST criteria at day 7 and after every 6 at 16 weeks during 2 years No
Secondary Validation of the technical and acquisition measurement models Validation of the technical and acquisition measurement models of tumor perfusion MRI and CT, and diffusion MRI, study of reproducibility at day 7 and after every 6 at 16 weeks during 2 years No
Secondary Assessment of potential drug costs Assessment of potential drug costs avoided by use of innovative prognostic criteria for adapting treatment at the end No
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