Technetium Tc-99m maraciclatide

Summary

Technetium Tc-99m maraciclatide (also known as 99mTc-NC100692 or Cortendo/GE Healthcare's RGD imaging agent) is a radiolabeled cyclic RGD peptide developed for SPECT imaging of αvβ3 integrin expression. It has been evaluated in clinical trials primarily for imaging tumor angiogenesis, breast cancer, and atherosclerosis. It has not received full regulatory approval for routine clinical use but has undergone Phase II clinical investigation.

Mechanism of Action

Cyclic RGD-containing peptide that selectively binds to αvβ3 and αvβ5 integrins expressed on activated endothelial cells and tumor neovasculature. When labeled with Technetium-99m (a gamma-emitting radionuclide), it enables SPECT imaging of angiogenesis and integrin expression in tissues such as tumors and atherosclerotic plaques.

Routes of Administration

Goals & Uses

• Lung cancer imagingDiagnostic OncologyLow
• Breast cancer lesion detectionDiagnostic OncologyModerate
• Assessment of anti-angiogenic therapy responseTheranostic MonitoringLow
• Atherosclerotic plaque imagingCardiovascular DiagnosticsLow
• Imaging tumor angiogenesisDiagnostic OncologyModerate

Contraindications

• Severe renal impairmentOrganModerateKidney function concerns
• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• Known hypersensitivity to RGD peptides or excipientsAllergyHigh
• BreastfeedingPopulationModeratePotential transfer into breast milk or insufficient safety data

Adverse Effects

• Radiation exposureRadiologicalCommon
• Injection site reactionsLocalUncommon
• Hypersensitivity/allergic reactionsImmunologicRare
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

• Other Tc-99m radiopharmaceuticalsModerate
• Anti-angiogenic agents (e.g., bevacizumab, sunitinib)Moderate

Population Constraints

• Pediatric patientsAgeRelative
• Breastfeeding womenReproductiveRelative
• Pregnant womenReproductiveAbsolute
• Patients with severe renal impairmentOrgan ImpairmentRelative

Regulatory Status

• European UnionInvestigationalClinical trials conducted under CTA in European countries; not EMA-approved.
• United StatesInvestigationalInvestigated under IND; Phase II trials completed; not FDA-approved for commercial use.
• United KingdomInvestigationalEvaluated in UK clinical trials including breast cancer SPECT studies; not approved for routine clinical use.

Investigated under IND/CTA in multiple jurisdictions. Phase II clinical trials conducted. Not currently FDA-approved or EMA-approved for routine clinical use as of the knowledge cutoff. Classified as an investigational radiopharmaceutical.

Evidence & Sources

No sources recorded yet.