Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000584033
Ethics application status
Approved
Date submitted
16/07/2010
Date registered
20/07/2010
Date last updated
20/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiotoxicity assessment by gated-single photon computed tomography (SPECT) in patients with previous breast cancer undergoing chemo- and/or radiotherapy
Scientific title
Cardiotoxicity assessment by gated-SPECT in patients with previous breast cancer undergoing chemo- and/or radiotherapy for comparison of coronary reserve
Secondary ID [1] 252237 0
none
Universal Trial Number (UTN)
U1111-1116-0977
Trial acronym
CFRBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiotoxicity in breast cancer 257755 0
Condition category
Condition code
Cancer 257933 257933 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Anthracyclines: one cycle once every 21 days for 4-6 cycles; bolus as per imput infusion (comprehensive procedure duration half an hour), 90 mg/m2: radiotherapy on chest 5 day per week for 6 weeks; overall 60 Gy. overall observation over 48 months
Intervention code [1] 256820 0
Not applicable
Comparator / control treatment
Coronary flow reserve (CFR) control pre and post-therapy;
All patients undergone single-day stress–rest 99mTc-tetrofosmin Myocardial Perfusion Imaging (MPI) by gated SPECT according to the European Association of Nuclear Medicine and European Society of Cardiology recommendations [Hesse B, Tagil K, Cuocolo A, Anagnostopoulos C, Bardies M, Bax J, et al. European Association of Nuclear Medicine (EANM)/European Society of Cardiology (ESC) procedural guidelines for myocardial perfusion imaging in nuclear cardiology. Eur J Nucl Med Mol Imaging 2005;32:855–97.]. A pharmacological dipyridamole-induced stress according to a standardized protocol is carried out monitoring heart rate and rhythm, blood pressure and electrocardiography (EKG).
At peak stress 370 MBq of 99mTc-tetrofosmin are injected intravenously. Two to three hours after the stress test, 1,110 MBq of 99mTc-tetrofosmin are injected at rest. Gated-SPECT imaging (16 frames per cardiac cycle) is executed 30 and 60 min after the tracer injection for the post-stress and rest study, respectively, using a dual head gamma camera. CFR calculation is carried out according to a validated method (Storto G et al. Estimation of coronary flow reserve by Tc-99m sestamibi imaging in patients with coronary artery disease: comparison with the results of intracoronary Doppler technique. J Nucl Cardiol. 2004 Nov-Dec;11(6):682-8.
Control group
Active

Outcomes
Primary outcome [1] 258802 0
CFR assessment by gated-SPECT
Timepoint [1] 258802 0
ad interim 6 months evaluation; final assessment at 48 months
Primary outcome [2] 258804 0
CFR assessment by gated-SPECT
Timepoint [2] 258804 0
ad interim 6 months evaluation; final assessment at 48 months
Secondary outcome [1] 264865 0
Nil
Timepoint [1] 264865 0
nil

Eligibility
Key inclusion criteria
patients with previous breast cancer undergoing chemo- and or radiotherapy
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
know coronary artery disease, cardiac heart failure (CHF), hypertrophic myocardiopathy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2769 0
Italy
State/province [1] 2769 0

Funding & Sponsors
Funding source category [1] 257294 0
Self funded/Unfunded
Name [1] 257294 0
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS); Centro di Riferimento Oncologico di Basilicata (CROB)
Country [1] 257294 0
Italy
Primary sponsor type
Hospital
Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS); Centro di Riferimento Oncologico di Basilicata (CROB)
Address
via P. Pio 1; 85028 Rionero in Vulture (Pz)
Country
Italy
Secondary sponsor category [1] 256539 0
None
Name [1] 256539 0
Address [1] 256539 0
Country [1] 256539 0
Other collaborator category [1] 251390 0
University
Name [1] 251390 0
Federico II
Address [1] 251390 0
via Pansini 5 , 80131 Naples
Country [1] 251390 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259321 0
IRCCS CROB
Ethics committee address [1] 259321 0
via P. Pio n 1; 85028 Rionero in Vulture (Pz)
Ethics committee country [1] 259321 0
Italy
Date submitted for ethics approval [1] 259321 0
Approval date [1] 259321 0
05/06/2007
Ethics approval number [1] 259321 0
377

Summary
Brief summary
Assessment of coronary flow reserve by non-invasive methodology (myocardial perfusion scintigraphy and cardiac function evaluation) in patients undergoing chemo- and or radio-therapy following breast cancer surgery.
Such non invasive procedure could be useful in detecting early microvascular coronary bed damages due to adiuvant interventions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31403 0
Address 31403 0
Country 31403 0
Phone 31403 0
Fax 31403 0
Email 31403 0
Contact person for public queries
Name 14650 0
Mr. Giovanni Storto MD FEBNM
Address 14650 0
via P. Pio 1, 85028 Rionero in Vulture (pz)
Country 14650 0
Italy
Phone 14650 0
+39-0972-726560
Fax 14650 0
Email 14650 0
[email protected]
Contact person for scientific queries
Name 5578 0
Mr. Giovanni Storto MD FEBNM
Address 5578 0
via P. Pio 1, 85028 Rionero in Vulture (Pz)
Country 5578 0
Italy
Phone 5578 0
+39-0972-726560
Fax 5578 0
Email 5578 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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