A clinical study using a radioactive imaging agent with PET-CT to detect neuroendocrine tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Voxel S.A.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-06-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The basis of the clinical study is the diagnostic and compliance of PET-CT imaging with the administration of V-Cu64-labeled DOTATOC in a patient with a diagnosed or suspected neuroendocrine tumor (NET) compared to PET-CT with the administration of 68Ga-labeled DOTATOC as the gold standard.

Secondary objectives 2

1. Confirmation of the equal effectiveness of the study with the administration of V-Cu64-labeled DOTATOC in imaging primary lesions and metastases.
2. Safety monitoring. Collection of data on adverse events.

Conditions and MedDRA coding

Neoplasms

Regulatory references

Plan to share IPD

No

IPD plan description

n/a

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1) Confirmation or suspicion of NET based on histology/biopsy report.
2. 2) Confirmation or suspicion of NET based on imaging tests such as: MRI and/or CT with contrast or FDG PET-CT and/or NaF PET-CT, performed no earlier than 8 weeks before the date of the examination.
3. 3) Confirmation or suspicion of NET based on biochemical tests, including elevated levels of: chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (5-HIAA in urine), gastrin, somatostatin, catecholamines, metanephrine, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon.
4. 4) confirmed familial predisposition to NET in patients with MEN1 and VHL (symptomatic and/or asymptomatic cases).
5. 5) The following laboratory test results within the specified ranges are required: ◦ WBC: > 2 × 10^9/L ◦ Hemoglobin: > 8.0 g/dL. ◦ Platelets: > 50 × 10^9/L. ◦ Serum creatinine: < 170 µmol/L
6. 6) Negative urine/blood pregnancy test OR postmenopausal for at least 2 years OR hysterectomy patient and consent to barrier or hormonal contraception during the clinical trial and for at least 3 months after its completion.

Exclusion criteria 5

1. 1) Pregnancy and lactation.
2. 2) No possibility of expressing written consent
3. 3) Therapeutic use of any somatostatin analogue within a minimum of 28 days before the PET-CT examination with the administration of DOTATOC labelled with the 68Ga radiopharmaceutical precursor.
4. 4) Acute or chronic clinically significant conditions, such as: uncontrolled congestive heart failure, liver dysfunction, renal dysfunction, uncontrolled hypertension.
5. 5) History of hypersensitivity to drugs with a similar chemical structure to the investigational product or to any of its excipients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Demonstration of the bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on number of visualized lesions between interventions. Number of visualized lesions (visualization of at least the same lesions between interventions) for 95% of the study population
2. Demonstration of bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on: SUV_MAX measurement of lesions imaged in both interventions. Accuracy in SUV_MAX measurement of lesions imaged in both interventions, SUV_MAX in the copper study not less than 90% of SUV_MAX in the 68Ga study for each lesion for 95% of the population, averaged result for descriptions by two independent physicians.

Secondary endpoints 1

1. Safety monitoring. Collection of data on adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Voxel S.A.

Sponsor organisation

Voxel S.A.

Address

Ul. Wielicka 265

City

Cracow

Postcode

30-663

Country

Poland

Scientific contact point

Organisation

Voxel S.A.

Contact name

Clinical Trial Manager

Public contact point

Organisation

Voxel S.A.

Contact name

Clinical Trial Manager

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications