177Lu-DOTA-FAPI Therapy

Phase 2

Recruiting

Conditions: 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 lung
Malignant neoplasm of prostate
Malignant neoplasm of overlapping sites of female genital organs
Malignant neoplasm of urinary organ, unspecified
Malignant neoplasm of breast
Malignant neoplasm of connective and soft tissue of head, face and neck

Registration Number: IRCT20210612051548N2

Lead Sponsor: Boushehr University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures