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99mTc-marked 14F7 MaB in metastatic breast, phase II
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9 April 2013 - 4:27pm
by Webmaster
23 January 2017 - 12:46pm
by lazara
Changes to
Clinical sites
-
Havana
City
, Hermanos Ameijeiras
hospital
, Adlin Lopez Diaz, Bachelor in Physics.
+
Havana, Hermanos Ameijeiras
Hospital
, Adlin Lopez Diaz, Bachelor in Physics.
Changes to
Research ethics committees
-
National Institute of Oncology and Radiobiology (INOR), July 23, 2004. Hermanos Ameijeiras
hospital
, June 30, 2007.
+
National Institute of Oncology and Radiobiology (INOR), July 23, 2004.
+
Hermanos Ameijeiras
Hospital
, June 30, 2007.
Changes to
First name
-
Juan
Perfecto Oliva Gonzalez, MD. 2nd degree specialist in oncology.
+
Juan
Changes to
Midle name
-
+
Perfecto
Changes to
Last name
-
Not entered
+
Oliva Gonzalez
Changes to
Health condition(s) code
-
+
Breast Neoplasms
+
Breast Diseases
Changes to
Medical Specialty
-
+
2nd degree specialist in oncology
Changes to
Affiliation
-
Not entered
+
National Institute of Oncology and Radiobiology (INOR)
Changes to
Postal address
-
Not entered
+
29 Street, corner F, Plaza
Changes to
Intervention code
-
+
Radionuclide Imaging
+
Radioimmunodetection
+
Antibodies, Monoclonal
+
Administration, Intravenous
+
Radioisotopes
+
Injections, Intra-Arterial
Changes to
Intervention keyword
+
AcM 14F7,
+
Immunoscintigraphy
Changes to
City
-
Not entered
+
Havana
Changes to
Country
-
Not entered
+
Cuba
Changes to
Zip Code
-
Not entered
+
10400
Changes to
Specialty
-
+
Specialist 2nd Grade in Normal and Pathological Physiology
Changes to
Postal Address
-
Calle
216
Esquina
15, Atabey, Playa
+
216
Street and
15, Atabey, Playa
Changes to
City
-
Havana
City
+
Havana
Changes to
Specialty
-
+
Specialist 2nd Grade in Normal and Pathological Physiology
Changes to
Postal Address
-
Calle
216
Esquina
15, Atabey, Playa
+
216
Street and
15, Atabey, Playa
Changes to
City
-
Havana
City
+
Havana
Changes to
Record Verification Date
-
2008-
01
-17 19:00
+
2017/
01
/23
Changes to
Next update date
-
+
2018/01/23
Revision of 23 January 2017 - 12:46pm:
99mTc-marked 14F7 MaB in metastatic breast, phase II
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Immuno gamma scanning with 99mTc-marked 14F7 MaB in patients with metastatic breast tumor
Secondary indentifying numbers:
IIC RD-EC073
Issuing authority of the secondary identifying numbers:
Center of Molecular Inmunology (CIM)
Primary sponsor:
Center of Molecular Inmunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Government funds
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of the Quality of Drugs(CECMED)
Authorization date :
05/01/2005
Reference number:
094/05.026.04B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Juan
Midle name:
Perfecto
Last name:
Oliva Gonzalez
Medical Specialty :
2nd degree specialist in oncology
Affiliation:
National Institute of Oncology and Radiobiology (INOR)
Postal address:
29 Street, corner F, Plaza
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78382578
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Havana, Hermanos Ameijeiras Hospital, Adlin Lopez Diaz, Bachelor in Physics.
Research ethics committees:
National Institute of Oncology and Radiobiology (INOR), July 23, 2004.
Hermanos Ameijeiras Hospital, June 30, 2007.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
29/10/2005
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Metastatic breast tumor
Health condition(s) code:
Breast Neoplasms
Breast Diseases
Intervention(s):
One single 1-mg dose of 30-40mCi of 99mTc-marked 14F7 MaB will be administered intravenously within 1-2 minutes, volume exceeding 1mL. Patients with metastasis located in contralateral breast will have the product administered through pedis artery.
Intervention code:
Radionuclide Imaging
Radioimmunodetection
Antibodies, Monoclonal
Administration, Intravenous
Radioisotopes
Injections, Intra-Arterial
Intervention keyword:
AcM 14F7, Immunoscintigraphy
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Gamma graphic positivity, Measuring time: 24 hours.
Key secondary outcomes:
Concordance degree, sensitivity, specificity, predictive positive value, predictive negative value, and Toxicity. Measuring time: 24 hours.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Female
Minimum age:
18 years
Maximum age:
80 years
Inclusion criteria:
1) Patients giving their consent in writing to participate in the clinical trial. 2) Patients with breast carcinoma, phase IV upon diagnosis, or evolving metastatic disease, with cyto-histological confirmation of base disease and of metastasis by imaging and cyto-histological tests. 3) Patients aged 18 to 80. 4) Patients whose general condition is lower than or equal to 2 under WHO criteria. 5) Preserved kidney function with creatinine values within normal limits (35-132 mmol/L). 6) Patients with hemoglobin values over 10g/L, leucocytes over 4,000/mm3, platelets 100 x 109, and transaminase and alkaline phosphatase up to 2.5 times higher than normal reference values. 7) Female patients will be included in the study.
Exclusion criteria:
1) Pregnancy and breastfeeding. 2) Reproductive-age patients not using contraceptive methods. 3) Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.5oC). 4) Patients with history of uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis, and high blood pressure. 5) Patients with allergic conditions or history of severe allergic reactions. 6) Patients who have previously been on any murine or humanized MAb therapy.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Diagnostic
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
2
Target sample size:
21
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Angel
Middle Name:
Raimundo
Last Name:
Casaco Parada
Specialty:
Specialist 2nd Grade in Normal and Pathological Physiology
Affiliation:
Center of Molecular Inmunology (CIM)
Postal Address:
216 Street and 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
CP 16040, Box11600
Telephone:
(537) 271-7933 Ext 224
Email :
casaco@cim.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Angel
Middle Name:
Raimundo
Last Name:
Casaco Parada
Specialty:
Specialist 2nd Grade in Normal and Pathological Physiology
Affiliation:
Center of Molecular Inmunology (CIM)
Postal Address:
216 Street and 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
CP 16040, Box11600
Telephone:
(537) 271-7933 Ext 224
Email :
casaco@cim.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000025
Date of Registration in Primary Registry:
2008-12-27
Record Verification Date:
2017/01/23
Next update date:
2018/01/23
Link to the spanish version:
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