Condition 1: Brain tumors. Condition 2: Thyroid cancer resistant to radioactive iodine therapy. Condition 3: Gastrointestinal tumor. Condition 4: Lung cancer. Condition 5: Prostate cancer. Condition 6: Malignant female genital organs. Condition 7: Urinary tract cancer. Condition 8: Breast cancer. Condition 9: Malignant neoplasm of head, face and neck. Malignant neoplasm of brain Malignant neoplasm of thyroid gland Malignant neoplasms of digestive organs Malignant neoplasm of bronchus and lun
Conditions
Interventions
Intervention group: In this study, 7.4 GBq (200 mCi) of 177Lu-DOTA-FAPI is injected intravenously into 30 patients with various types of cancers that demonstrated high FAP expression according to the
Sponsors
Boushehr University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: The presence of at least one tumoral lesion detected by 68Ga-DOTA-FAPI PET/CT or 99mTc-DOTA-FAPI SPECT Having hematologic parameters as: (i) Absolute neutrophil count = 1000 cells/mm3; (ii) Platelet count = 100,000/mm3; (iii) Hemoglobin = 8 g/dL Participants who sign the informed consent form which was assented according to the guidelines of the Clinical Research Ethics Committee (signed by participant, parent, or legal representative). Eastern Cooperative Oncology Group Performance Status (ECOG) = 2
Exclusion criteria
Exclusion criteria: Patient had history of class 3 or 4 congestive heart failure (CHF) Patient had clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding) Pregnant or lactating women Patient have psychiatric illness/social situations that would interfere with compliance with study requirements Patient cannot undergo PET/CT or SPECT scanning because of weight limits Patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Tumour Response Rate - defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) divided by the total number of participants. Timepoint: 6-8 week after last session of treatment. Method of measurement: Observation and semi-quantification analysis via PET/CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PSF). Timepoint: Average 2 years. Method of measurement: Medical imaging. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMajid Assadi
Boushehr University of Medical Sciences
Outcome results
None listed