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ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)

Primary Purpose

Medullary Thyroid Carcinoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
• TF2 and 68 Ga-IMP-288
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Medullary Thyroid Carcinoma focused on measuring thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angers Hospital
  • Nantes Hospital
  • Institut de Cancérologie de l'ouest, René Gauducheau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TF2 antibody/68Ga-IMP-288

Arm Description

TF2 coupled with 68 Ga-IMP-288

Outcomes

Primary Outcome Measures

Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
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

Sensibilité

Full Information

First Posted
November 12, 2012
Last Updated
July 22, 2022
Sponsor
Nantes University Hospital
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01730638
Brief Title
ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
Acronym
iTEP-CMT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medullary Thyroid Carcinoma
Keywords
thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TF2 antibody/68Ga-IMP-288
Arm Type
Experimental
Arm Description
TF2 coupled with 68 Ga-IMP-288
Intervention Type
Drug
Intervention Name(s)
• TF2 and 68 Ga-IMP-288
Other Intervention Name(s)
• 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
Primary Outcome Measure Information:
Title
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Sensibilité
Time Frame
6 monts after immunoTEP
Other Pre-specified Outcome Measures:
Title
tolerance
Time Frame
6 monts after immunoTEP
Title
a second _iTEP if necessary for the follow up of a lesion
Description
with in the follow up of the pateint
Time Frame
6 monts after immunoTEP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francoise Bodere, PhD, MD
Organizational Affiliation
Nantes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers Hospital
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Nantes Hospital
City
Nantes
ZIP/Postal Code
44100
Country
France
Facility Name
Institut de Cancérologie de l'ouest, René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

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ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

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