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Completed

NCT Number: NCT01730638

ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Angers Hospital, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

• TF2 and 68 Ga-IMP-288

Drug

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

Primary outcomes

  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 outcomes

  1. Sensibilité

    Time frame: 6 monts after immunoTEP

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Gilead Sciences
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study 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.

Acronym: iTEP-CMT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2012
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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