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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jagiellonian University
• Collaborators: Medical University Innsbruck; NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom; University Medical Centre Ljubljana; University of Ljubljana

Criteria

Inclusion Criteria:

1. Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.

2. Age ≥ 21 years

3. Male and female patients with cytologically/histologically confirmed NEN (G1 - G2) with SSTR positivity in molecular imaging (SPECT/PET - within 2 months before inclusion)

4. Karnofsky performance status ≥60%

5. Life expectancy of more than 6 months

6. 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.

7. 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).

The regulations for contraception are derived from Guideline ICH E8 Chapter 3.2.2.1 Selection of subjects together with ICH M3 note 4.

Exclusion Criteria:

1. Renal insufficiency with an eGFR <45 ml/min/1.73 m2 or intolerance to any constituents of intravenous CT-contrast agents

2. Higher than grade 2 hematotoxicity (CTC >2)

3. Co-existing malignancies (except non-melanoma skin carcinoma and uterine cervix carcinoma -in-situ unless without evidence of recurrence for 5 years)

4. Patients with concurrent illnesses/history of somatic/psychiatric disease that might preclude study completion or interfere with study results

5. Patients with bladder outflow obstruction or unmanageable urinary incontinence

6. Illness/clinically relevant trauma within 2 weeks before study entry

7. Pregnancy; breast-feeding; females planning to bear a child recently or with childbearing potential, unless a commonly accepted effective means of contraception is used

8. Prior administration of a radiopharmaceutical for SPECT-imaging within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical.

9. Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease.

10. Known or expected hypersensitivity to somatostatin analogues or to any excipient of the study drug

11. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

12. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.

13. Subjects with any kind of dependency on the investigator or is employed by the sponsor or investigator

14. Subjects held in an institution by legal or official order