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Palliative therapy of bone metastases by Radiopharmaceuticals

Evaluation of the efficacy of Re-188 hydroxyethylidene diphosphonic acid (Re-188 HEDP) in palliative therapy of multiple bone metastases

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201109181100N3
Enrollment
20
Registered
2011-10-15
Start date
2011-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Bone metastasis. Condition 2: Malignant neoplasms. Malignant neoplasm of bone and articular cartilage of limbs Malignant neoplasm of bone and articular cartilage of other and unspecified sites

Interventions

Intravenous single injection of 1 mCi/kg of Re-188 hydroxyethylidene diphosphonic acid.
Treatment - Drugs
Intravenous single injection of 1 mCi/kg of Re-188 hydroxyethylidene diphosphonic acid

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients (>20 yr) with multiple skeletal metastasis of a known cancer who have intractable bone pain; Multiple painful bone metastases; Positive bone scan (within 6 wk); abnormal uptake (>1 site) corresponding to pain sites; Estimated life expectancy 2 months especially for agents with longer half-life; No chemotherapy or external beam radiation during 4-6 weeks before therapy with agent (This is particularly important when long-acting agents such as nitrosoureas have been given); WBC>2500 (some reports 3500); Platelet>60,000. Exclusion Criteria: Acute or chronic renal failure; Acute spinal cord suppression; who need to external radiation therapy; A solitary metastatic site; Extensive soft tissue metastases; Evidence of disseminated intravascular coagulopathy; Prior to myelosuppressive chemotherapy; Impending pathologic fracture; Hemoglobin < 90 g.L-1; Total white cell count < 2500 (some reports 3500); Absolute neutrophil count < 1500; Platelets < 60,000; Glomerular filtration rate < 30 mL/min; Pregnancy; breastfeeding; women of child-bearing age.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bone pain. Timepoint: 2, 4 and 8 weeks elapsed from intervention. Method of measurement: Standardized questionaire.

Secondary

MeasureTime frame
Bone marrow suppression. Timepoint: 2, 4 and 8 weeks elapsed from intervension. Method of measurement: Peripheral cell blood count.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Babak Fallahi

Research Institute for Nuclear Medicine, Tehran University of Medical Sciences

bfallahi@sina.tums.ac.ir+98 21 8863 3333

Outcome results

None listed

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