177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

  • STATUS
    Recruiting
  • End date
    Mar 25, 2022
  • participants needed
    24
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 25 January 2021
ct scan
cancer
progressive disease
targeted therapy
calcitonin
gastrin

Summary

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

Details
Condition Medullary Thyroid Cancer, Thyroid Cancer, Medullary, Medullary Thyroid Carcinoma, Thyroid Cancer, Medullary, Thyroid Cancer, Medullary, Thyroid Cancer, Medullary, Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2, Neuroendocrine Tumor of the Thymus Grade 1 and 2, Neuroendocrine Tumor GEP Grade 1-3, Thyroid Cancer, Medullary, Neuroendocrine Tumor GEP Grade 1-3, Neuroendocrine Tumor GEP Grade 1-3
Treatment 177Lu-PP-F11N
Clinical Study IdentifierNCT02088645
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase 0 study
Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
Age > 18 years
Informed consent
Phase I study
Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
Informed consent
Curative surgical therapy not possible

Exclusion Criteria

Phase 0 study
Medication with Vandetanib 3 weeks before the study and during the study
Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface)
Bone marrow failure (thrombocytes < 70 000/l, leucocytes < 2 500/l, hemoglobin < 8 g/dl)
Pregnancy and breast feeding
Knows allergic reaction on Physiogel or other gelatine products
Known, serious side reaction in the case of a former application of pentagastrin
Active, second malignancy oder remission after second malignancy < 5 years
Phase I study
Medication with Vandetanib 3 weeks before the study and during the study
Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface)
Bone marrow failure (thrombocytes < 100 000/l, leucocytes < 3 000/l, hemoglobin < 10 g/dl)
Pregnancy and breast feeding
Known, serious side reaction in the case of a former application of pentagastrin
Active, second malignancy oder remission after second malignancy < 5 years
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