Thyroid Cancer, MedullaryPhase 1LumedNCT02088645

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

A Phase 1 study testing 177Lu-PP-F11N in people with Thyroid Cancer, Medullary and Neuroendocrine Tumor of the Lung Grade 1 and 2, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2, Neuroendocrine Tumor of the Thymus Grade 1 and 2
What is being tested?: 177Lu-PP-F11N
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSwitzerland
Study dates: Apr 2015to Apr 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Basel, Clinic for radiology and nuclear medicine
Basel, 4031

Other trials in Switzerland

About this study

Official title: 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

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).

Conditions: 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
Being tested: 177Lu-PP-F11N
Keywords: Calcitonin, Medullary thyroid carcinoma, Peptide receptor radionuclide therapy, Gastrin, Cholecystokinin-2 receptor, Neuroendocrine tumor
Medical subject headings: Thyroid cancer, medullary, Carcinoma, Medullary, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

177Lu-PP-F11NDrug
Also called Minigastrin analogue, Gastrin analogue, Cholecystokinin-2 receptor ligand

Study groups in NCT02088645
Study group	Role	What they receive
Phase 0: One arm; Phase I: One arm	Experimental	Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover) Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study. Receives: Drug: 177Lu-PP-F11N

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 0: Scintigraphic visualisation rate
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).
Measured: up to 4 weeks
Phase I: Maximum tolerated dose
Phase I study: Determination of the maximum tolerated dose (MTD)
Measured: Up to 9 months

Secondary outcomes (12)

Phase 0: Tumour-to-kidney radiation doses
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
Measured: 8 and 16 weeks
Phase 0: Radiation doses
Calculation of tumour and organ radiation doses.
Measured: 8 and 16 weeks
Phase 0: In vivo stability
Evaluation of in vivo stability of 177Lu-PP-F11N.
Measured: 8 and 16 weeks
Phase 0: Metabolites
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
Measured: 8 and 16 weeks
Phase I: Side reactions
Evaluation of side reactions of 177Lu-PP-F11N.
Measured: 8, 16 and 24 weeks
Phase 1: Biochemical response
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
Measured: For the duration of 24 months.
Phase I: Morphological response
Evaluation of morphological therapy response (RECIST criteria).
Measured: 0, 3 and 12 months
Phase I: Tumour detection rate
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
Measured: 8, 16 and 24 weeks
Phase I: Organ radiation doses
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
Measured: 8, 16 and 24 weeks
Phase 1: Overall survival
Determination of overall survival of patients after therapy.
Measured: Up to 5 years
Phase 1: In vivo stability
Evaluation of in vivo stability of 177Lu-PP-F11N.
Measured: 8, 16 und 24 weeks
Phase 1: Metabolites
Measurement of the metabolites of 177Lu-PP-F11N.
Measured: 8, 16 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Apr 2028

First posted17 Mar 2014 (estimated)
Study startApr 2015
Primary completionApr 2027 (estimated)
Study completionApr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Thyroid Cancer, MedullaryStudies of the same condition, open and under way.
More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02088645
Sponsor's protocol ID: KFS-3170-02-2013
Acronym: Lumed
Status last verified: Apr 2026
First submitted: 19 Feb 2014
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 30002107
Rottenburger C, Nicolas GP, McDougall L, Kaul F, Cachovan M, Vija AH, Schibli R, Geistlich S, Schumann A, Rau T, Glatz K, Behe M, Christ ER, Wild D. Cholecystokinin 2 Receptor Agonist 177Lu-PP-F11N for Radionuclide Therapy of Medullary Thyroid Carcinoma: Results of the Lumed Phase 0a Study. J Nucl Med. 2020 Apr;61(4):520-526. doi: 10.2967/jnumed.119.233031. Epub 2019 Sep 13.
PubMed 31519804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.
ClinicalTrials.gov ID: NCT02088645
Acronym / sponsor ID: Lumed / KFS-3170-02-2013
Conditions: 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
Keywords: Calcitonin, Medullary thyroid carcinoma, Peptide receptor radionuclide therapy, Gastrin, Cholecystokinin-2 receptor, Neuroendocrine tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: University Hospital, Basel, SwitzerlandUniversity, hospital or other
Collaborators: Krebsforschung Schweiz, Bern, Switzerland, Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, University Hospital, Zürich, University Hospital Freiburg
Study start: Apr 2015
Primary completion: Apr 2027 (estimated)
Study completion: Apr 2028 (estimated)
First posted: 17 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Phase 0: One arm; Phase I: One arm	Experimental	Drug: 177Lu-PP-F11NPhase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover) Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
177Lu-PP-F11NAlso: Minigastrin analogue, Gastrin analogue, Cholecystokinin-2 receptor ligand	Drug	Phase 0: One arm; Phase I: One arm

Primary outcome

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)

12 secondary outcomes

Phase 0: Tumour-to-kidney radiation doses
Time frame: 8 and 16 weeks
Phase 0: Radiation doses
Time frame: 8 and 16 weeks
Phase 0: In vivo stability
Time frame: 8 and 16 weeks
Phase 0: Metabolites
Time frame: 8 and 16 weeks
Phase I: Side reactions
Time frame: 8, 16 and 24 weeks
Phase 1: Biochemical response
Time frame: For the duration of 24 months.
Phase I: Morphological response
Time frame: 0, 3 and 12 months
Phase I: Tumour detection rate
Time frame: 8, 16 and 24 weeks
Phase I: Organ radiation doses
Time frame: 8, 16 and 24 weeks
Phase 1: Overall survival
Time frame: Up to 5 years
Phase 1: In vivo stability
Time frame: 8, 16 und 24 weeks
Phase 1: Metabolites
Time frame: 8, 16 and 24 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Background: PubMed 30002107Sauter 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.
Background: PubMed 31519804Rottenburger C, Nicolas GP, McDougall L, Kaul F, Cachovan M, Vija AH, Schibli R, Geistlich S, Schumann A, Rau T, Glatz K, Behe M, Christ ER, Wild D. Cholecystokinin 2 Receptor Agonist 177Lu-PP-F11N for Radionuclide Therapy of Medullary Thyroid Carcinoma: Results of the Lumed Phase 0a Study. J Nucl Med. 2020 Apr;61(4):520-526. doi: 10.2967/jnumed.119.233031. Epub 2019 Sep 13.
Homepage University Hospital BaselLink provided by the sponsor.

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christof Rottenburger, Dr. med. principal investigator

University Hospital, Basel, Switzerland

Damian Wild, Prof Dr Dr study director

University Hospital, Basel, Switzerland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 0: Scintigraphic visualisation rate (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088645, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.