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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Medullary Thyroid Carcinoma

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Trial Information

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.


Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed
in 3 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.

Whole-body PET images will be recorded 60 to 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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 3 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. 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.

Outcome Time Frame:

one week

Safety Issue:

No

Principal Investigator

Francoise Bodere, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes Hospital

Authority:

France : Agence National de Sécurité du Médicament (ANSM)

Study ID:

BRD 11/5-L

NCT ID:

NCT01730638

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Medullary Thyroid Carcinoma
  • thyroid,
  • endocrine tumour
  • Nuclear medicine,
  • molecular imaging
  • ImmunoTEP
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases

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