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Trial record 1 of 1 for:    NCT01730638
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ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730638
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 26, 2022
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Gilead Sciences
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Medullary Thyroid Carcinoma Drug: • TF2 and 68 Ga-IMP-288 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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 Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TF2 antibody/68Ga-IMP-288
TF2 coupled with 68 Ga-IMP-288
 Drug: • TF2 and 68 Ga-IMP-288
Other Names:
  • • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
  • • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Sensibilité [ Time Frame: 6 monts after immunoTEP ]

Other Outcome Measures:
  1. tolerance [ Time Frame: 6 monts after immunoTEP ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730638


Locations
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France
Angers Hospital
Angers, France, 49100
Nantes Hospital
Nantes, France, 44100
Institut de Cancérologie de l'ouest, René Gauducheau
Saint-Herblain, France, 44805
Sponsors and Collaborators
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Gilead Sciences
Investigators
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Principal Investigator: Francoise Bodere, PhD, MD Nantes Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01730638    
Other Study ID Numbers: PROG/10/94
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: May 2017
Keywords provided by Nantes University Hospital:
thyroid,
endocrine tumour
Nuclear medicine,
molecular imaging
ImmunoTEP
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Histamine
Glycine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Glycine Agents