Colon/rectum tumor
Conditions
Interventions
A single administration of 1mg of 14f7 MAb marked with 30-40 mCi 99mTc. The product will be intravenously administered in a 1 to 2 minute time span and a volume higher than 1mL
Radionuclide Imaging
Antibodies, Monoclonal
Administration, Intravenous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients expressing their consent in writing to participate in the clinical trial. 2.Patients between 18 and 80 years of age. 3.Patients without another neoplasia history, except basal skin carcinoma or in situ cervical carcinoma. 4.Patients with general health condition lower than or equal to 2, according to WHO criteria. 5.Preserved kidney function with a creatinine parameter lower than 132 mmol/l. 6.Patients with hemoglobin values over 10 g/l, leukocytes over 4000 /mm3, platelets 100 x 109 and transaminase and alkaline phosphatase within 2.5 times the normal reference values. 7.The study will include patients of both sexes.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or breastfeeding. 2.Reproductive-age patients not using contraceptive methods. 3.Fever due to acute or serious infectious diseases or convalescence (not exceeding 37oC). 4.Patients with history of decompensated chronic diseases such as: asthma, ischemic heart disease, diabetes mellitus, hepatitis and high blood pressure. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients previously treated with murine or humanized MAb.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive responses. Measuring time: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance grade, sensitivity, specificity, positive predictive value, negative predictive value, toxicity. Measuring time: 1 month after treatment. | — |
Countries
Cuba
Contacts
Public ContactAngel Casaco Parada
Center of Molecular Immunology (CIM)
Outcome results
None listed