Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05871320
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05871320
Study Brief:
Protocol Section:
NCT05871320