Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms

NCT05871320 | Completed Early Phase 1

• 2 other identifiers: TECANT2019-003379-20
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 3

Brief Summary

The main goal of the study is to expand cancer preclinical research results on the usefulness of SSTR2-Antagonist \[99mTc\]Tc-TECANT1 in clinical practice. Detection of NEN and monitoring of response to therapy is still challenging due to their cellular heterogeneity. Initial preclinical studies suggest that NEN imaging with the use of SSTR2-Antagonist may be advantageous in comparison to the widely used SSTR2-Agonists. Recently, novel radiopharmaceuticals, based on SSTR2-Antagonists, were shown to provide superior SSTR2 visualisation than currently used agonists. The need for molecular imaging of NEN is expected to grow significantly in the near future due to their increasing incidence and prevalence. Although a persistent trend to shift the molecular imaging of NEN from conventional SPECT/CT gamma cameras to PET/CT has been observed in the last decade, labelling the compound with Tc-99m offers significant advantages by its extremely wide availability, low cost and low radiation exposure to patients. Effective and accessible molecular imaging methods as an integral part of personalised patient management are needed to optimise selection and follow-up of available therapeutic modalities. The Tc-99m-labeled SSTR2-Antagonist \[99mTc\]Tc-TECANT1 is expected to be an effective, widely available compound for quantitative assessment of SSTR2 NEN status, allowing a personalised therapeutic approach.

Conditions

Neuroendocrine Tumors

Keywords

Somatostatin receptors; neuroendocrine neoplasms; Positron emission tomography; Peptide Receptor Radionuclide Therapy; Single-photon emission computed tomography; SSTR2 antagonist; 99mTc; NEN tumour; Tc-99m-labeled SSTR2-Antagonist

Outcome Measures

Primary Outcomes (4)

• Safety and Tolerability assessment - incidence of Treatment-Emergent Adverse Events of iv administration of TECANT1 radiolabeled with 740±10% MBq of 99mTc

  The number of patients with treatment-related adverse events as assessed by CTCAE v.5.0 (time frame: 2 weeks after administration)CTCAE v.5.0 (time frame: 2 weeks after administration)

  14 days

• Dosimetry assessment - effective dose absorbed in critical organs

  Effective dose counted based on absorbed dose (energy deposited per unit mass) adjusted for radiation type and relative organ sensitivity measured in sievert (Sv)

  2 days

• Assessment of ionization radiation related to injection of TECANT1

  Assessment of effective absorbed dose per injected activity \[mSv/MBq\] for critical organs (bone marrow, kidneys, bladder wall) and neoplastic lesions

  2days

• Analysis of human pharmacokinetics of TECANT1

  1. Calculation of biological half-life of Tc-99m -SSTR2-Antagonist \[99mTc\]Tc-TECANT1 in blood (min) (based on time-activity curves) 2. Assessment of the biological half-life of Tc-99m-SSTR2-Antagonist \[99mTc\]Tc-TECANT1 (min) in normal organs, tumour lesions (based on time-activity curves)

  2 days

Secondary Outcomes (1)

• Evaluation of [99mTc]Tc-TECANT01 uptake in tumour lesions.

  14 days

Study Arms (1)

[99mTc]Tc-TECANT1

EXPERIMENTAL

The injection volume will be up to 5 mL over 20 seconds with an activity of 10 MBq/kg body weight (range between min. 500 and max. 800 MBq). To ensure application of the complete activity additionally 10 mL of 0.9% saline will be infused via the same system.

Drug: [99mTc]Tc-TECANT1

Interventions

[99mTc]Tc-TECANT1 DRUG

only one arm - the administration of \[99mTC\]-Tc-TECANT1 in all patients included

[99mTc]Tc-TECANT1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
• Age ≥ 21 years
• Karnofsky performance status ≥60%
• Life expectancy of more than 6 months
• Participating men must use a single barrier method for contraception for at least 6 months after completion of the trial starting at the day of application of \[99mTc\]Tc-TECANT1.
• Women of childbearing age must use two highly effective methods of contraception during the trial and 6 months after application of investigational product if not in menopause or after hysterectomy.
• The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective:
• Oral hormonal contraception ("pill") (as far as its efficacy is not expected to be impaired during the trial, e.g. with IMPs that cause vomiting and diarrhoea, adequate safety cannot be assumed)
• Dermal hormonal contraception
• Vaginal hormonal contraception (NuvaRing®)
• Contraceptive plaster
• Long-acting injectable contraceptives
• Implants that release progesterone (Implanon®)
• Tubal ligation (female sterilisation)
• Double barrier methods This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).

You may not qualify if:

• Renal insufficiency with an eGFR \<45 ml/min/1.73 m2 or intolerance to any constituents of intravenous CT-contrast agents
• Higher than grade 2 hematotoxicity (CTC \>2)
• Co-existing malignancies (except non-melanoma skin carcinoma and uterine cervix carcinoma -in-situ unless without evidence of recurrence for 5 years)
• Patients with concurrent illnesses/history of somatic/psychiatric disease that might preclude study completion or interfere with study results
• Patients with bladder outflow obstruction or unmanageable urinary incontinence
• Illness/clinically relevant trauma within 2 weeks before study entry
• Pregnancy; breast-feeding; females planning to bear a child recently or with childbearing potential, unless a commonly accepted effective means of contraception is used
• Prior administration of a radiopharmaceutical for SPECT-imaging within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical.
• Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease.
• Known or expected hypersensitivity to somatostatin analogues or to any excipient of the study drug
• History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
• Subjects with any kind of dependency on the investigator or is employed by the sponsor or investigator
• Subjects held in an institution by legal or official order

Sponsors & Collaborators

• Jagiellonian University: lead
• Medical University Innsbruck: collaborator
• NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom: collaborator
• University of Ljubljana: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (3)

Innsbruck Medical University Department of Nuclear Medicine

Innsbruck, Austria

Location

Department of Endocrinology, Jagiellonian University Medical College

Krakow, 30-688, Poland

Location

University Medical Centre Ljubljana Department of Nuclear Medicine

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Alicja Hubalewska-Dydejczyk, Prof.

  Endocrinology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center, Phase 0/I study, prospective single-arm, open-label study

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: May 23, 2023
• Study Start: December 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); PL (1); SL (1)