DRUG
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
Status
Active, not recruiting
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 17, 2014
Study start
Apr 2015
Primary completion
Apr 2027
Study completion
Apr 2028
Results posted
Not reported
Registry updated
May 1, 2026
Outcomes
What the study measures.
Primary outcomes
Phase 0: Scintigraphic visualisation rate
Time frame · up to 4 weeks
Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).
Phase I: Maximum tolerated dose
Time frame · Up to 9 months
Phase I study: Determination of the maximum tolerated dose (MTD)
Secondary outcomes
Phase 0: Tumour-to-kidney radiation doses
Time frame · 8 and 16 weeks
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
Phase 0: Radiation doses
Time frame · 8 and 16 weeks
Calculation of tumour and organ radiation doses.
Phase 0: In vivo stability
Time frame · 8 and 16 weeks
Evaluation of in vivo stability of 177Lu-PP-F11N.
Phase 0: Metabolites
Time frame · 8 and 16 weeks
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
Phase I: Side reactions
Time frame · 8, 16 and 24 weeks
Evaluation of side reactions of 177Lu-PP-F11N.
Phase 1: Biochemical response
Time frame · For the duration of 24 months.
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
Phase I: Morphological response
Time frame · 0, 3 and 12 months
Evaluation of morphological therapy response (RECIST criteria).
Phase I: Tumour detection rate
Time frame · 8, 16 and 24 weeks
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
Phase I: Organ radiation doses
Time frame · 8, 16 and 24 weeks
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
Phase 1: Overall survival
Time frame · Up to 5 years
Determination of overall survival of patients after therapy.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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/μl, leucocytes \< 2 500/μl, 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/μl, leucocytes \< 3 000/μl, 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
Study locations
1 registered sites.
Switzerland. Showing up to 24 locations stored in the fast local snapshot.
University Hospital Basel, Clinic for radiology and nuclear medicine
Basel, Switzerland
Publications
Results and literature.
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