ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.
some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Angers, France, 49100
- Angers Hospital
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Nantes, France, 44100
- Nantes Hospital
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Saint-Herblain, France, 44805
- Institut de Cancérologie de l'Ouest, René Gauducheau
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TF2 antibody/68Ga-IMP-288
TF2 coupled with 68 Ga-IMP-288
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
Time Frame: one week
|
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. |
one week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensibilité
Time Frame: 6 monts after immunoTEP
|
6 monts after immunoTEP
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tolerance
Time Frame: 6 monts after immunoTEP
|
6 monts after immunoTEP
|
|
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a second _iTEP if necessary for the follow up of a lesion
Time Frame: 6 monts after immunoTEP
|
with in the follow up of the pateint
|
6 monts after immunoTEP
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: francoise Bodere, PhD, MD, Nantes Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Carcinoma
- Thyroid Diseases
- Thyroid Neoplasms
- Carcinoma, Neuroendocrine
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Histamine Agents
- Glycine Agents
- Histamine Agonists
- Glycine
- Histamine
Other Study ID Numbers
- PROG/10/94
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