Azedra (iobenguane I 131) / Lantheus - LARVOL DELTA

Response-adapted consolidation therapy strategy for patients with metastatic high-risk neuroblastoma: Results of the SMC NB-2014 study. (PubMed, Pediatr Blood Cancer) - "Our results suggest that response-adaptive consolidation therapy based on chemotherapy response at metastatic sites facilitates better treatment tailoring, and appears promising for patients with metastatic high-risk neuroblastoma."

Journal • Metastases • Bone Marrow Transplantation • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor • Transplantation

Phase I Study of 131I-Metaiodobenzylguanidine With Dinutuximab ± Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A New Approaches to Neuroblastoma Therapy Trial. (PubMed, J Clin Oncol) - "MIBG combined with dinutuximab was well tolerated with encouraging antitumor activity. Vorinostat added to this combination may augment responses in this heavily pretreated patient population."

Journal • P1 data • Fatigue • Neuroblastoma • Oncology • Pneumonia • Solid Tumor

PI3K inhibition with alpelisib and idelalisib enhances mIBG uptake in a preclinical neuroblastoma model (EANM 2026) - "We have previously demonstrated that administration of fimepinostat (CUDC-907), a dual histonedeacetylase and phosphoinositide 3-kinase (PI3K) inhibitor, enhances mIBG uptake both in vitro and in vivo in a NB xenograft mouse model.1 Since fimepinostat lacks regulatory approval, we investigated further clinically approved PI3K inhibitors to extend this strategy toward clinical translation. Both alpelisib and idelalisib significantly enhance [123I]mIBG tumour uptake in a NB xenograft, reinforcing PI3K inhibition as a viable strategy to improve mIBG-based theranostics. Idelalisib demonstrated the more favourable profile with consistent enhancement and low variability at the effective dose. Therapeutic studies combining these PI3K inhibitors with [131I]mIBG are underway to determine whether this ~40% increase in tumour uptake translates into improved treatment efficacy in the same preclinical model, with the aim of supporting future clinical translation."

Preclinical • Neuroblastoma • Solid Tumor • PIK3CA • PIK3CD

Preoperative MIBG Uptake Predicts Perioperative Myocardial Injury in Patients Receiving Surgery for Pheochromocytoma and Paraganglioma (EANM 2026) - "Patients who received 131I-MIBG scintigraphy before surgery for PPGL were included in this study... Patients with intense preoperative MIBG uptake has higher chance to suffer from perioperative myocardial injury. When using MIBG uptake score 5 as a threshold, high sensitivity and negative predictive value could be achieved, which may guide preoperative risk stratification and patient preparation."

Clinical • Surgery • Neuroendocrine Tumor • Solid Tumor

Uptake of radiolabeled-mIBG in neuroblastoma cells, spheroids, and xenograft model (EANM 2026) - "Materials and The specific uptake of radiolabeled-mIBG by neuroblastoma cell lines SHSY5Y, SKNBE(2), SKNAS, SKNDZ, SKNSH, IMR32, and neuro2a is measured in vitro with cells pre-treated with norepinephrine transporter (NET) inhibitors, desipramine, or non-radiolabeled mIBG. Real-time binding measurements can be used to study 123I- and 131I-mIBG uptake and retention in neuroblastoma cells and spheroids. It could reduce the workload of evaluating mIBG uptake at different time points and serve as an alternative to using laboratory animals with neuroblastoma xenograft models. A SPECT/CT study is planned to compare the in vitro uptake of 123I-/131I-mIBG to in vivo distribution."

Preclinical • Neuroblastoma • Solid Tumor

Impact of 131I-MIBG dose escalation (12 vs. 18 mCi/kg) during conditioning for autologous hematopoietic stem cell transplantation in pediatric neuroblastoma: a retrospective cohort study. (PubMed, Eur J Pediatr) - " In this retrospective cohort, escalation from 12 to 18 mCi/kg was associated with faster neutrophil engraftment and a higher rate of normal MIBG scans at 1 year, without a significant difference in OS or EFS. The study was underpowered, and did not demonstrate a significant benefit of either the lower or the higher dose; the optimal dose remains undetermined and requires prospective evaluation."

Journal • Retrospective data • Bone Marrow Transplantation • Neuroblastoma • Oncology • Pediatrics • Solid Tumor • Transplantation

SPORE-3: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: David Bushnell | Initiation date: Mar 2021 ➔ Sep 2021

First-in-human • Trial initiation date • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

SPORE-3: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: David Bushnell | Initiation date: Nov 2020 ➔ Mar 2021

First-in-human • Trial initiation date • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

SPORE-3: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: David Bushnell

First-in-human • New P1/2 trial • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

SPORE-3: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: David Bushnell | N=50 ➔ 0 | Trial completion date: Oct 2025 ➔ Apr 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Oct 2025 ➔ Apr 2024

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial withdrawal • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

SPORE-3: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: David Bushnell | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

A case of metastasectomy following multiple courses of radionuclide therapy for distant metastatic pheochromocytoma. (PubMed, JCEM Case Rep) - "Sequential 131I-MIBG and 177Lu-DOTATATE therapies were administered, which contributed to disease control and reduction of catecholamine levels but did not achieve a complete response. This case suggests that metastasectomy may be preferable to radionuclide therapy in carefully selected patients with limited, resectable metastatic disease, despite the presence of distant and multiple metastases. Furthermore, it highlights the importance of periodic reassessment of resectability in patients with distant metastases, even when radionuclide therapy is initially selected, and consideration of metastasectomy once complete resection becomes feasible."

Journal • Neuroendocrine Tumor • Oncology • Solid Tumor

Single Autologous Stem Cell Rescue After Single or Tandem 131I-Metaiodobenzylguanidine Therapy, With or Without Subsequent Chemotherapy, for Resistant Neuroblastoma: Feasibility, Toxicity, and Response. (PubMed, Pediatr Blood Cancer) - P2 | "In selected patients with resistant neuroblastoma, sequential MIBG therapy with chemotherapy can be delivered with a single ASCR, potentially conserving stem cell aliquots. Given the modest responses and the toxicities encountered, novel agents rather than tandem MIBG therapy or chemotherapy should be considered to optimize the role of MIBG therapy."

Journal • Hematological Disorders • Neuroblastoma • Oncology • Solid Tumor

To Radiate or Not: The Role of Consolidative Radiotherapy to Post-Induction MIBG-Avid Sites in High-Risk Neuroblastoma (ASTRO 2026) - "Included patients had MIBG-avid metastatic disease at diagnosis and first relapse, achieved partial or complete response before first relapse, and did not receive total body radiation or 131I-MIBG therapy prior to relapse... In this cohort, ~40% of recurrences occurred in prior residual post-induction chemo MIBG-avid sites, and 30% of patients who recurred had initial recurrences only in previously MIBG-avid sites that were not irradiated, suggesting that consolidative metastatic site RT may have been beneficial in these patients. Radiated sites achieved 100% LC, however 94% of non-irradiated sites also did not recur, indicating that the large majority of metastatic sites may not need consolidative RT and that appropriate selection and weighing benefits vs risks is important. Further studies are needed to elucidate prognostic factors to better risk-stratify which patients and sites would benefit most from consolidative metastatic site RT."

Neuroblastoma • Oncology • Solid Tumor

A Phase III Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Lorlatinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (ANBL1531) (ASTRO 2026) - P3 | "All arms include definitive surgical resection, tandem autologous stem cell transplantation, and post-consolidation immunotherapy with dinutuximab, sargramostim, and isotretinoin. TBD"

Clinical • IO biomarker • P3 data • Neuroblastoma • Oncology • Solid Tumor • ALK

Future scenarios of radioligand therapy in pheochromocytomas and paragangliomas. (PubMed, EJNMMI Rep) - "RLT represents a valuable therapeutic option for patients with progressive or symptomatic PPGL. Advances in molecular imaging, alphaemitter therapies, and personalized dosimetry are expected to further refine treatment selection and improve outcomes. Larger prospective studies are needed to define optimal sequencing and integration into clinical practice."

Journal • Review • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab (clinicaltrials.gov) - P2 | N=118 | Not yet recruiting | Sponsor: New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Jul 2031 ➔ Dec 2031 | Initiation date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2030 ➔ Dec 2030

Trial completion date • Trial initiation date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Current Applications of Molecular Imaging in Adrenal Imaging. (PubMed, Magn Reson Imaging Clin N Am) - "Targeted radiopharmaceutical therapies, 131I-MIBG and 177Lu-DOTATATE (Lutathera), and newer theranostic agents can provide personalized treatment plans for patients. This review discusses molecular imaging based on adrenal tumor biology, receptor expression, and genetic mutations, the imaging characteristics of common adrenal lesions, and current and future therapeutic treatments."

Journal • Review • Adrenal Cortex Carcinoma • Oncology • Solid Tumor

Neuroblastoma imaging: From MIBG to advanced PET tracers. (PubMed, Semin Nucl Med) - "Furthermore, MIBG serves as a theranostic agent, enabling targeted radionuclide therapy with 131I-MIBG in patients with relapsed or refractory disease...This review provides a comprehensive overview of contemporary neuroblastoma imaging, tracing the transition from MIBG-based scintigraphy to advanced PET tracers and emerging theranostic approaches. Understanding the complementary roles of these imaging modalities is essential for optimizing patient management and improving outcomes in children with this complex and heterogeneous malignancy."

Journal • Review • Neuroblastoma • Oncology • Pediatrics • Solid Tumor • SSTR

First-in-human, open-label, single-arm phase 1 study of [211At] meta-astatobenzylguanidine in patients with pheochromocytoma or paraganglioma. (PubMed, Clin Cancer Res) - "A single dose of 211At-MABG at 2.1 MBq/kg was well tolerated and demonstrated predictable pharmacokinetics. Preliminary antitumor activity was observed, including one partial response during the 12-week period. These findings establish the clinical feasibility of ²¹¹At-MABG and provide a translational foundation for multi-dose, dose-escalation, and biomarker-stratified trials."

First-in-human • Journal • P1 data • Oncology • Solid Tumor

Molecular Imaging and Radioligand Therapies in Pheochromocytomas and Paragangliomas. (PubMed, Endocr Relat Cancer) - "High-specific-activity 131I-MIBG has demonstrated durable disease control, symptomatic improvement, and favorable safety in multicenter studies, leading to FDA approval for metastatic PPGL, although currently not commercially available. More recently, peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE has shown disease control rates of 80-100% in prospective and retrospective trials, with outcomes enhanced by standardized dosing strategies. Ongoing studies are evaluating PRRT in genetically defined subgroups and exploring synergistic combinations, including radiosensitizing approaches."

Journal • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Systemic Management of Adrenal Malignancies: Adrenocortical carcinoma and pheochromocytoma/paraganglioma. (PubMed, Endocr Connect) - "When rapid tumor control is needed, etoposide, doxorubicin, cisplatin, and mitotane remains the standard first-line regimen...Cyclophosphamide, vincristine, and dacarbazine may be considered for aggressive disease, rapid growth, or high tumor burden. Targeted and radiopharmaceutical approaches have expanded options, including high-specific-activity 131I-iobenguane for MIBG-avid tumors, 177Lu-DOTATATE for somatostatin receptor-positive disease, antiangiogenic tyrosine kinase inhibitors, and HIF-2α inhibition with belzutifan in selected molecular contexts. For both ACC and PPGL, controlling steroid or catecholamine excess is crucial, because endocrine complications affect treatment tolerance and outcomes. Future progress requires robust biomarkers, rational treatment sequencing, and trials using disease-specific endpoints beyond radiographic response and integrating patient-centered endocrine, molecular, and overall clinical measures of benefit."

IO biomarker • Journal • Adrenal Cortex Carcinoma • Endocrine Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • EPAS1 • SSTR

Ultrasound-guided, nursing-led, phase-based swallowing rehabilitation in elderly patients with MIBG-positive medullary thyroid carcinoma following 131I-MIBG therapy. (PubMed, Front Med (Lausanne)) - "Participation in ultrasound-guided, nursing-led, phase-based swallowing rehabilitation was associated with significant improvements in swallowing function, muscle performance, nutritional status, and quality of life in elderly patients with MIBG-positive MTC after 131I-MIBG therapy. This approach appears safe, feasible, and scalable for geriatric oncology rehabilitation."

Journal • Gastrointestinal Disorder • Infectious Disease • Oncology • Otorhinolaryngology • Pneumonia • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

Application of 131I-MIBG imaging in assessing renal sympathetic overdrive in heart failure with preserved ejection fraction (HFpEF). (PubMed, Am J Transl Res) - "131I-MIBG imaging successfully quantifies renal-cardiac sympathetic crosstalk in HFpEF. The markedly elevated K/M ratios demonstrate that renal sympathetic overactivity is a core driver of hemodynamic congestion in these patients. Clinically, this technique may serve as a powerful non-invasive biomarker to identify candidates for sympatho-inhibitory therapies and provides a precise tool for monitoring therapeutic efficacy in HFpEF management."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Pulmonary Disease

Imaging of Adrenal and Extra-Adrenal Paraganglioma. (PubMed, Semin Ultrasound CT MR) - "Contemporary consensus places somatostatin‑receptor analogues (SSAs) such as 68Ga-DOTATATE and 64Cu-DOTATATE at the center of head‑and‑neck paraganglioma (HNPGL), SDHx‑mutated disease, sporadic or hereditary HNPGLs and metastatic PPGLs, while 18F‑FDOPA is increasingly favored for adrenal pheochromocytoma (PCC); and 18F‑FDG complements both by detecting aggressive biology. MIBG now is only considered for inoperable or metastatic PPGLs under consideration for 131I‑MIBG therapy."

Journal • Review • Endocrine Cancer • Oncology • Solid Tumor • SSTR