177Lu-FAPI in cancer therapy

Phase 1

Conditions: end-stage metastatic gastrointestinal or breast cancer.

Registration Number: IRCT20211206053304N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 10

Inclusion Criteria

the patient should be able to understand and sign off the informed consent.
The patient should be able to understand and follow the treatment protocol.
Patients should be older than 18.
The patients life expectancy should be over 6 months.
patients should show no response to the standard treatment.
The 68Ga-FAPI PET scan or 99mTc-FAPI SPECT scan should show 3 times more uptake of radiopharmaceutical in tumor to liver of the patients.
the patient with progressive disease should be included.

Exclusion Criteria

The patients who have received therapeutic radiopharmaceuticals like, 223Ra, 188Re, 186Re, 153Sm during last 6 months.
The patients are under systemic therapies like chemotherapy, immunotherapy, or biological treatment for cancer.
The patients who have been under any research treatment during 28 days before entrance in this study.
The patients who have shown any known allergy to the therapeutic radiopharmaceuticals.
The patients who have congestive heart failure.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of pain feeling on the bone. Timepoint: Just before treatment and every 4 weeks after treatment. Method of measurement: Using Visual Analogue Scale questionnaire.;Performance Status (quality of life). Timepoint: Before treatment and every 4 weeks after treatment. Method of measurement: Eastern Cooperative Oncology Group (ECOG) Performance Status.

Secondary Outcome Measures