Current partner codePEPTIDESDE
NCT02088645·Phase 1·INTERVENTIONAL

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.

DRUG

177Lu-PP-F11N

Timeline

From registration to results.

  1. First posted

    Mar 17, 2014

  2. Study start

    Apr 2015

  3. Primary completion

    Apr 2027

  4. Study completion

    Apr 2028

  5. Results posted

    Not reported

  6. 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

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.