F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection

NCT07907250 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Not applicable

Started

2026-01-01

Last updated

2026-10-30

Condition(s) studied

Plantar FascitisChronic Heel Pain

Investigational drug(s) / intervention(s)

Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anestheticPatients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic

Patients receiving F-18 NaF PET/CT-guided Lutetium-177 - corticosteroid - local anesthetic: After confirming the needle position at the target site by F18 NaF PET/CT, 1-2 mCi of Lutetium-177, 30 mg corticosteroid and 0.5ml bupivacaine will be injected.

Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid - local anaesthetic: After confirming the needle position at the target site by F18 NaF PET/CT, 30 mg corticosteroid and 0.5ml bupivacaine will be injected.

Study summary

Study type: Prospective, randomized, comparative pilot clinical study.

Purpose of the study: The goal of this study is to evaluate whether adding low-dose, F-18 sodium fluoride (NaF) PET/CT-guided intralesional Lutetium-177 therapy to corticosteroid and local anaesthetic injection provides better pain relief and functional improvement than PET/CT-guided corticosteroid and local anaesthetic injection alone in patients with chronic plantar fasciitis who have not responded to conservative treatment for more than six months.

Participant population: Adults aged 18-80 years with chronic plantar fasciitis lasting more than six months, failure of conservative treatment, a baseline visual analogue scale (VAS) pain score of ≥4, and focal uptake at the plantar fascia insertion on F-18 NaF PET/CT. The study plans to recruit 40 participants, with 20 participants in each group.

Primary Outcomes:

1\. Improvement in foot-specific pain and function, assessed by the change in the Manchester-Oxford Foot Questionnaire (MOXFQ) score, and health-related quality of life, assessed by the SF-12 questionnaire, from baseline to three months.

Secondary outcomes :

1. Change in pain intensity measured by VAS (0-10).
2. Change in osteoblastic activity measured by SUVmax on F-18 NaF PET/CT,
3. Safety and tolerability at three and six months

Comparison groups:

Group A (intervention): F-18 NaF PET/CT-guided injection of Lutetium-177 (37-74 MBq; 1-2 mCi) combined with corticosteroid (30 mg) and local anaesthetic.

Group B (comparison): F-18 NaF PET/CT-guided injection of corticosteroid (30 mg) and local anaesthetic.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age 18-80 years with chronic plantar fasciitis (\>6 months). 2. Failed to conservative therapy. 3. Baseline VAS ≥4. 4. Focal uptake at plantar fascia insertion on F-18 NaF PET/CT. Exclusion Criteria: 1. Prior radiation therapy to the foot/heel. 2. Active infection at the injection site or systemic infection. 3. Pregnancy or lactation. (Pregnancy test for women of childbearing potential.) 4. Coagulopathy (INR \>1.5 or platelets \<100,000/µL) is not correctable. 5. Uncontrolled diabetes or severe peripheral vascular disease affecting wound healing. 6. Known allergy to agents would be used for local anaesthesia or to any component of the injection.

Primary outcome measure(s)

Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire) — 3 months from baseline
Change in Manchester-Oxford Foot Questionnaire (MOXFQ score) and 12-Item Short Form Health Survey (SF-12 questionnaire) from baseline to 3 months.

Trial sites (1)

Facility	City	Region	Status
Postgraduate Institute of Medical Education and Research, Chandigarh	Chandigarh	Chandigarh	Recruiting