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177Lu-FAPI in cancer therapy

Initial evaluation of the therapeutic efficacy of 177Lu-FAPI in patients with various end-stage metastatic cancers resistant to standard therapies

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211206053304N1
Enrollment
10
Registered
2022-08-22
Start date
2022-09-23
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end-stage metastatic gastrointestinal or breast cancer.

Interventions

Intervention group: the selected patients go through PET/CT (68Ga-FAPI radiopharmaceutical about 6 mCi dose) or SPECT/CT (99mTc-FAPI radiopharmaceutical about 20 mCi dose) scan at first. The therapeut

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Hassanzadeh

Iran University of Medical Sciences

Hassanzadeh.l@iums.ac.ir+98 21 2235 5715

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026