. Author manuscript; available in PMC: 2024 Dec 1.

Published in final edited form as: Nat Rev Mater. 2023 Jul 26;8(12):783–798. doi: 10.1038/s41578-023-00581-x

Table 3 |. Completed Clinical Trials for Nanotheranostics.

Imaging modality	Therapy	Nano-particle	clinical application	Phase	Last Update	Reference	Results	Comments
Magnetic Resonance Imaging	surgery	SPIO	sentinel node	NA	06/2017 06/2019 10/2020 10/2020 09/2022	NCT01927887 NCT02739425 NCT01815333 NCT03898687 NCT05054062	Y N Y N P	SPIO for lymph node visualization in melanoma patients
	small molecule	USPIO	neuro-inflammation	NA	07/2022	NCT02549898	P	no correlation between neuroinflammation and USPIO signal enhancement
	small molecule	USPIO	neuro-inflammation	Phase 1	03/2023	NCT02511028	N	-
	cell therapy	SPIO	cell mobility & retention	NA	06/2021	NCT00972946	P	safety and feasibility of cell labeling with SPIO for MRI tracking
				Phase 1	08/2018	NCT03651791	P
				Phase 1/2	03/2021	NCT00781872	N	-
	Cell tracking	USPIO	inflammation in cardiovascular disorders	NA	02/2013 12/2014 04/2015	NCT01169935 NCT01323296 NCT00368589	P P P	safety and feasibility of cell labeling with SPIO for MRI tracking
	Cell tracking	USPIO	inflammation in cardiovascular disorders	Phase 2/3	05/2017	NCT02319278	P
	nutritional supplement	SPIO	iron deficiency	NA	03/2014	NCT01374919	P	safety of Ferumoxytol
				Phase 2	05/2018	NCT01052779	P	efficacy of Ferumoxytol vs iron sucrose
				Phase 3	01/2015 01/2015 06/2018 04/2022 04/2022 04/2022	NCT00255437 NCT00255424 NCT02694978 NCT01114204 NCT01114139 NCT01114217	P P P Y Y Y	safety of i.v. iron therapy in kidney disease patients
				Phase 4	03/2012 04/2022	NCT01148745 NCT01227616	Y P	safety of Ferumoxytol in chronic kidney disease patients
	magnetic hyperthermia	SPIO	prostate cancer	Phase 0	05/2017	NCT02033447	N	-
	radiation therapy	AGuIX	brain tumor and metastasis	Phase 1	06/2019	NCT02820454	P⁷⁷	AGuIX phase I study protocol in brain metastasis patients
	photothermal therapy	AuroShell	prostate cancer head & neck	NA	02/2017 03/2021	NCT00848042 NCT02680535	Y P	demonstration of a software for mapping tissue ablation and preoperative planning
	irinotecan liposomes	SPIO	breast cancer and solid tumors	Phase 1	11/2019	NCT01770353	P	efficacy of liposomal irinotecan in metastatic breast cancer patients
Nuclear Imaging	Nanomedicine	⁸⁹Zr-CPC634	multiple solid tumors	Phase 1	10/2020	NCT03712423	P¹⁰⁸	localization of ⁸⁹Zr-CPC634 in malignant tissue
		⁶⁴Cu-MM-302	Breast Cancer Brain Tumours	Phase 1	01/2017 n/a	NCT01304797 NCT02735798	P¹⁰⁷ N	localization of ⁶⁴Cu-MM-302 in malignant tissue product withdrawn (trial never started)
		¹⁸⁸Re-liposome	solid tumors	Phase 1	10/2014	NCT02271516	N	study terminated for safety concerns
Computed Tomography	radiation therapy	NBTXR3	sarcoma	Phase 1	10/2020	NCT01433068	N	-
Computed Tomography	radiation therapy	NBTXR3	sarcoma	Phase 2/3	04/2021	NCT02379845	P	demonstration of NBTXR3 as theramostic nanoparticles
Optical Imaging	surgery	carbon NP	sentinel node	NA	03/2016	NCT02724176	P	demonstration of carbon nanoparticles for patient stratification
		ONM-100	Cancer (breast, lungs, prostate, ovarian, lungs…)	Phase 2	11/2022	NCT03735680	N	-
		ONM-100	Lung cancer	Phase 2	03/2023	NCT05048082	N	-

NA means that the trial didn’t have FDA-defined phases. Y indicates results posted at clinicaltrials.gov, N results not posted, and P results published in a scientific manuscript. SPIO: super-paramagnetic iron oxide nanoparticles; USPIO: ultra-small SPIO; Carbon NP: carbon nanoparticle; C-dots: carbon dots; NanoTherm: iron oxide nanoparticle, AGuIX: polymeric gadolinium complexes, AuroShell: silica gold nanoshell, NBTXR3: hafnium oxide nanoparticles; ONM-100: fluorescent imaging nanoparticles; 89Zr-CPC634: 89Zr-labeled polymeric nanoparticles carrying docetaxel; 64Cu-MM-302: 64Cu- labeled liposomes carrying doxorubicin; 188Re-liposome: 188Re-labeled liposomes.