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14F7 MAb marked with Tc99 Phase II in breast tumors.
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10 Abril 2013 - 9:15am
por Webmaster
23 Enero 2017 - 12:30pm
por lazara
Cambios a
First name
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Juan
Perfecto Oliva Gonzalez, MD, PhD in Medical Sciencies. 2nd degree Specialist in Oncology.
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Juan
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Midle name
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Perfecto
Cambios a
Last name
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Not entered
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Oliva Gonzalez
Cambios a
Health condition(s) code
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Breast Neoplasms
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Breast Diseases
Cambios a
Medical Specialty
-
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2nd degree Specialist in Oncology
Cambios a
Affiliation
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Not entered
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National Institute of Oncology and Radiobiology (INOR)
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Postal address
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Not entered
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29 Street, corner F, Plaza
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Intervention code
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Radionuclide Imaging
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Radioimmunodetection
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Antibodies, Monoclonal
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Administration, Intravenous
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Radioisotopes
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Injections, Intra-Arterial
Cambios a
Intervention keyword
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AcM 14F7,
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Immunoscintigraphy
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City
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Not entered
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Havana
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Country
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Not entered
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Cuba
Cambios a
Zip Code
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Not entered
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10400
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Specialty
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Specialist 2nd Grade in Normal and Pathological Physiology
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Postal Address
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Calle
216
Esquina
15, Atabey, Playa
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216
Street and
15, Atabey, Playa
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City
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Havana
City
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Havana
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Zip Code
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CP 16040,
Box11600
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CP 16040,
Box 11600
Cambios a
Specialty
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+
Specialist 2nd Grade in Normal and Pathological Physiology
Cambios a
Postal Address
-
Calle
216
Esquina
15, Atabey, Playa
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216
Street and
15, Atabey, Playa
Cambios a
City
-
Havana
City
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Havana
Cambios a
Zip Code
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CP 16040,
Box11600
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CP 16040,
Box 11600
Cambios a
Record Verification Date
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2008-
01
-17 19:00
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2017/
01
/23
Cambios a
Next update date
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2018/01/23
Revisión de 23 Enero 2017 - 12:30pm
14F7 MAb marked with Tc99 Phase II in breast tumors.
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 using 14F7 MAbB marked with Tc99 in patients with metastatic breast tumor, phase II.
Secondary indentifying numbers:
IIC RD-EC061
Issuing authority of the secondary identifying numbers:
Center of Molecular Immunology (CIM)
Primary sponsor:
Center of Molecular Immunology (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 :
27/09/2002
Reference number:
154/05.043.01B
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
País:
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:
Not applicable
Research ethics committees:
National Institute of Oncology and Radiobiology (INOR), July 24, 2001
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
13/02/2003
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 tumors.
Health condition(s) code:
Breast Neoplasms
Breast Diseases
Intervention(s):
One single 1mg dose of 14F7 MaB marked with 30-40mCi of 99mTc will be administered intravenously within 1-2 minutes (volume over 1 ml). Patients with metastasis 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):
Toxicity. Measuring time: 24 hours.
Key secondary outcomes:
Pharmacokinetics, biodistribution, internal dosage and gammagraphic positive tests. 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 (to participate in the clinical trial) in writing. 2)Patients with breast carcinoma phase IV upon diagnosis or evolving metastatic disease, with cyto-histological confirmation of base disease and metastasis by imaging or cyto-histological test. 3)Patients aged between 18 and 80 both inclusive. 4)Patients with general condition lower than or equal to 2, according to WHO criteria. 5)Preserved kidney function with normal creatinine values ranking from 35 to 132mmol/l. 6)Patients with hemoglobin values over 10g/l, leucocytes over 4,000 /mm3, platelets 100 x 109, transaminase and alkaline phosphatase up to 2.5 times over normal reference values.
Exclusion criteria:
1)Pregnancy or breastfeeding. 2)Reproductive-age patients not using contraceptives. 3)Feverish condition due to acute or serious infectious diseases or convalescence (not exceeding 37.5 oC). 4)Patients who have suffered from decompensated chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis or high blood pressure. 5)Patients with acute allergic conditions or severe allergic reaction history. 6)Patients who have previously been on some murine or humanized MAb.
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:
15
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 Immunology (CIM)
Postal Address:
216 Street and 15, Atabey, Playa
City:
Havana
País:
Cuba
Zip Code:
CP 16040, Box 11600
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 Immunology (CIM)
Postal Address:
216 Street and 15, Atabey, Playa
City:
Havana
País:
Cuba
Zip Code:
CP 16040, Box 11600
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:
RPCEC00000024
Date of Registration in Primary Registry:
2010-12-29
Record Verification Date:
2017/01/23
Next update date:
2018/01/23
Link to the spanish version:
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