DRUG
177Lu-PP-F11N
Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer
Status
Completed
Phase
Early Phase 1
Enrollment
8
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.
Full detailed description
A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.
Interventions
Treatment arms and agents.
DRUG
Sacuitril
Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N
Timeline
From registration to results.
First posted
Aug 27, 2018
Study start
Dec 13, 2018
Primary completion
Dec 14, 2021
Study completion
Dec 14, 2021
Results posted
Not reported
Registry updated
Feb 10, 2022
Outcomes
What the study measures.
Primary outcomes
Tumor radiation doses
Time frame · Measurement up to 72 hours after each injection of 177Lu-PP-F11N
Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)
Secondary outcomes
Kidney radiation doses
Time frame · Measurement up to 72 hours after each injection of 177Lu-PP-F11N
Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)
Organ radiation doses
Time frame · Measurement up to 72 hours after each injection of 177Lu-PP-F11N
Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)
In-vivo stability
Time frame · Blood samples for measurement 5 and 30 minutes post injection of 177Lu-PP-F11N
Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto).
Autoradiography
Time frame · Through study completion, up to 18 months
In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Advanced MTC with elevated levels of calcitonin (\> 100 pg/ml) and/or calcitonin-doubling time \< 24 months before or after total thyroidectomy * 68Ga-DOTATOC PET/CT not older than 12 weeks * Age \> 18 years * Informed consent Exclusion Criteria: * 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 * Known, serious side reaction in the case of a former application of pentagastrin * Active, second malignancy oder remission after second malignancy \< 5 years * Age over 64 years * Systolic bood pressure \< 112 mmHg at the time of screening * Simultaneous medication with angiotensin converting enzyme (ACE)-inhibitors, or withdrawal for less than 36 h prior to the medication with Entresto or simultaneous medication with AT-II-receptor blockers * Known intolerance to Sacubitril or Valsartan * Known angioedema in anamnesis in the context of a medication with an ACE-inhibitor or an AT-II-receptor blocker
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.
PMID 30002107 ↗Sauter AW, Mansi R, Hassiepen U, Muller L, Panigada T, Wiehr S, Wild AM, Geistlich S, Behe M, Rottenburger C, Wild D, Fani M. Targeting of the Cholecystokinin-2 Receptor with the Minigastrin Analog 177Lu-DOTA-PP-F11N: Does the Use of Protease Inhibitors Further Improve In Vivo Distribution? J Nucl Med. 2019 Mar;60(3):393-399. doi: 10.2967/jnumed.118.207845. Epub 2018 Jul 12.PMID 38581480 ↗Rottenburger C, Hentschel M, Furstner M, McDougall L, Kottoros D, Kaul F, Mansi R, Fani M, Vija AH, Schibli R, Geistlich S, Behe M, Christ ER, Wild D. In-vivo inhibition of neutral endopeptidase 1 results in higher absorbed tumor doses of [177Lu]Lu-PP-F11N in humans: the lumed phase 0b study. EJNMMI Res. 2024 Apr 6;14(1):37. doi: 10.1186/s13550-024-01101-w.
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