Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis (EMOS)

Breast Cancer Clinical Trial

Official title:

Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900118
• Other study ID #: EMOS-1207
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 8, 2016
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Breast cancers are among the cancers that metastasize the most to the skeleton. The appearance of bone metastasis, whether they are initials or during a relapse, is a turning point of the disease, due to the additional morbidity they imply (pain, pathologic fractures, hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the efficacy of this treatment in order to know whether to continue or change it depending on the response observed. But there is no consensus at this time on paraclinical examinations enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is formally validated and evaluation in routine practice remains subjective.

The main objective of our study is to determine if the PET-CT and the whole-body MRI are in agreement on the status of bone metastasis (stability, progression, partial response, complete response).

Description:

The oncologist includes patients responding to criteria and not opposing the collection of their data. He submits a request for whole-body MRI and PET-CT to the Medical Imaging and Nuclear Medicine departments of the Oscar Lambret Centre. If the patient has benefited within the previous 15 days of any of these examinations, it is not performed again : it will serve as an initial examination. Following these examinations, the oncologist completes the reading grid. A clinical examination and a questioning with the main stages of the disease is performed and data are reported in the dedicated sheet. A prescription of tumor markers and of bone remodeling is performed (in the absence of recent results), and the results are reported on the same sheet.

After 3 cycles (of intravenous chemotherapy) or 3 months of hormone therapy, the oncologist submits a new request for whole-body MRI and PET-CT. The MRI and PET-CT should conclude to a status : progression, stability, partial response, complete response. The reading grid is completed again. MDA criteria (MRI and PET-CT), PERCIST and EORTC (PET-CT only) are determined. Target lesions (1 to 3) are defined for each examination and a measure of the ADC and the SUV is performed for each lesion on the initial and follow-up examinations.

After these examinations, the patient is reviewed by his oncologist for a new clinical examination, the announcement of the status of bone metastasis and the possible adaptation of the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with breast cancer bone metastasis :

• at the initial diagnosis (group 1).

• in a metastatic bone relapse (group 2).

• with a progression of bone metastasis (group 3).

2. Treatment (hormone therapy, chemotherapy) not undertaken (group 1) or prior therapeutic change (group 2 and 3).

3. Patient not opposing the use of its data.

Exclusion Criteria:

1. Claustrophobic patient

2. Patient with an uncontrolled diabetes (fasting glucose < 1.6 g / l)

3. Patient with a pace-maker or another material incompatible with the MRI 3 Tesla

4. Very algetic patient (Visual Analog Scale (VAS) > 7)

5. Pregnant or breastfeeding women

6. Patient under 18 or under guardianship

7. Movement disorders (Parkinson disease, etc.) or dementia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the therapeutic response.		Cycle 3 (each cycle is 28 days)	No
Secondary	Evaluation of the concordance of the Apparent Diffusion Coefficient (ADC) and the Standardized Uptake Value (SUV).		At baseline	No
Secondary	Evaluation of the concordance of the Apparent Diffusion Coefficient (ADC) and the Standardized Uptake Value (SUV).		Cycle 3 (each cycle is 28 days)	No
Secondary	Evaluation of the consistency in the detection of lesions.		Cycle 3 (each cycle is 28 days)	No
Secondary	Evaluation of the criteria PERCIST (PET Response Criteria in Solid Tumors)		Cycle 3 (each cycle is 28 days)	No
Secondary	Evaluation of the criteria MDA (Minimal Disease Activity)		Cycle 3 (each cycle is 28 days)	No
Secondary	Evaluation of the criteria EORTC (European Organisation for Research and Treatment of Cancer).		Cycle 3 (each cycle is 28 days)	No