Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma. Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;
* 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule. Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours Cohort II: based on the results of the cohort I : 1. Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours 2. Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours 3. Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours Cohort III: based on results of cohort II: \- Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV • A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h • In the four weeks prior to the immuno-PET: \- Clinical examination, \- CEA and CA15-3, \- thoraco abdominal pelvic scan, bone scan, FDG-PET, \- immunohistochemistry ACE on the tumor if possible, \- Anti-Antibodies if the patient has already received MAb, \- pregnancy test within 2 days prior to immuno-PET, \- (creatinine \> 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging Evaluation at 1 month of Immuno-PET: • Assessment of the clinical oncologist and \- histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact Evaluation at 3 and 6 months of immuno-PET: based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist, \- Imaging (ultrasound, bone scintigraphy, CT or PET FDG), \- markers * Anti-Antibody Search * For patient with a cancer treatment a new immuno-PET can be proposed
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
ImmunoTEP
Hospital
Nantes, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288
Time frame: One week
Sensibility, tolerance
sensitivity of the immuno-PET and compare its performance to standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months by RECIST and EORTC
Time frame: 6 months after immunoTEP
To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
6 weeks after initiation of treatment of metastases (after the first iTEP), a second \_iTEP with a therapeutic evaluation will be carried out. The examination requirements are identical to those of the first immunoTEP. this second iITEP will be evaluated in regard of imaging assessment performed routinely (TAP scanner, FDG-PET, CA15-3 and CEA)
Time frame: month 6
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