Clinical trial · Interventional
ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.
NCT01730638CI-TRIAL-00059898iTEP-CMTcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medullary Thyroid Carcinoma | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| • TF2 and 68 Ga-IMP-288 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TF2 antibody/68Ga-IMP-288
- description
- TF2 coupled with 68 Ga-IMP-288
- interventionNames
- Drug: • TF2 and 68 Ga-IMP-288
Primary outcomes (1)
- measure
- Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
- timeFrame
- one week
- description
- Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of CMT * Calcitonin\> 150 pg / ml * Complete treatment of the primary tumor * at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable. * Age ≥ 18 years * Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months. * KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months * Absence of serious illness or co-morbidity assessed risk * Creatinine ≤ 2.5 normal * Absence of cancer treatment within 6 weeks prior to the immuno-PET * No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix * Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein * Informed consent signed * Social Insurance Exclusion Criteria: * Pregnancy or breastfeeding * Serious illness or co-morbidity assessed risk * History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix * Presence of anti-antibodies in patients who have previously received antibodies * Known hypersensitivity to antibody or protein * Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months) * Inability intellectual sign consent * Patient protected by law
References
Publications (0)
Data not yet available
No reference posted for this study.