Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Share on facebook
Facebook
Share on twitter
Twitter
Share on pinterest
Pinterest
Share on whatsapp
WhatsApp
Share on email
Email

Edit 4th September 2020.   64Cu-dotatate now named Detectnet™ is approved for use by US FDA. Majority read revealed Detectnet had over 98% accuracy, 100% sensitivity, and over 96% specificity to confirm or exclude presence of disease. Read more here

Edit 14th July 2020.  Expanded Access Program via clinical trial now recruiting – see below.  The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of SSTR expressing NETs.

Edit 22 Aug 2019.  US FDA announced approval of Ga68 DOTATOC.  There’s an overlap to this story.  Read more here.

Edit 10 Jan 2019: RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate.  Read more by clicking here.

Curium and RadioMedix Inc. announce an exclusive agreement to develop and commercialize 64Cu-Dotatate, an investigational positron emission tomography (PET) diagnostic agent for patients with Neuroendocrine Tumors (NETs). RadioMedix is currently engaged in Phase III clinical trials of the agent and expects to file a New Drug Application with the Food and Drug Administration in 2019. This partnership builds on the initial development work conducted by RadioMedix and will benefit from Curium’s regulatory, manufacturing, distribution, and commercial expertise. The radionuclide is not new, it’s been in use for some time, mainly in Denmark.

64Cu is a PET isotope that can be produced at a central location in quantities to meet the commercial needs of hospitals and imaging centers without the supply limitations of nuclear generator-based PET isotopes,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “Once approved, 64Cu-Dotatate will be available to patients in medical centers with PET capability across the country. This will address the shortage or lack of availability of somatostatin analogue PET agents that we are currently experiencing in many parts of the U.S.”

Ga68 PET Shortages explained

This statement is in relation to the current shortage of Ga68 PET radionuclide. For those not aware, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) has written a letter to the FDA about ongoing shortages of generators that produce gallium-68 (Ga-68), a radioisotope used regularly in medical imaging. The letter—available here.

The letter explains that Ga-68 is currently used to produce NETSPOT from Advanced Accelerator Applications (a Novartis company), which was approved in June 2016 to help treat neuroendocrine tumors (NETs) in adult and pediatric patients using PET. NETSPOT, however, is only approved using specific generators. And those generators are only approved for either 400 uses or one year, whichever comes first. This has led to shortages throughout the United States.

SNMMI notes some possible remedies for this shortage. For instance, “a temporary exemption to the 400-elution limit would have a major impact on NETSPOT capacity for patients,” according to the letter. In addition, using a wider variety of generators to produce NETSPOT or using cyclotron-produced gallium chloride are two other methods that could improve production in a relatively short amount of time. “Further discussion with the manufacturers is necessary,” the authors added.

Read more about Ga68 PET and its use in Neuroendocrine Cancer – click here. Worth also noting that RadioMedix is also involved in a number of NET related initiatives including:

1. Trials for a new type of PRRT called ‘Targeted Alpha-emitter Therapy (TAT) – I’ve written about this previously. Read my article here.
2. An exclusive distributor for the TM Isotopen Technologien München AG (ITM) PRRT product currently in trial. I wrote about this here.

How does 64Cu-Dotatate compare with Ga68 PET and Octreotide Scans?

To learn more about previous studies on 64Cu-Dotatate, here’s 2 articles published in the Journal of Nuclear Medicine which are a head to head comparison of 64Cu-Dotatate with Ga68 Dotatoc and with 111 Indium Octreotide (Octreoscan).

Head-to-Head Comparison of 64Cu-DOTATATE and 68Ga-DOTATOC PET/CT: A Prospective Study of 59 Patients with Neuroendocrine Tumors – http://jnm.snmjournals.org/content/58/3/451.full

PET/CT (left) and PET (right) scans of patient with intestinal NET and multiple metastases. More lesions are seen in intestinal region with 64Cu-DOTATATE than with 68Ga-DOTATOC.

Conclusion: 64Cu-DOTATATE has advantages over 68Ga-DOTATOC in the detection of lesions in NET patients. Although patient-based sensitivity was the same for 64Cu-DOTATATE and 68Ga-DOTATOC in this cohort, significantly more lesions were detected by 64Cu-DOTATATE. Furthermore, the shelf life of more than 24 h and the scanning window of at least 3 h make 64Cu-DOTATATE favorable and easy to use in the clinical setting.

64Cu-DOTATATE PET for Neuroendocrine Tumors: A Prospective Head-to-Head Comparison with 111In-DTPA-Octreotide in 112 Patients –http://jnm.snmjournals.org/content/56/6/847.full

Multiple small liver metastases (>10), peritoneal solitary tumor mass, and 3 lymph node metastases shown on 64Cu-DOTATATE PET/CT in patient with pancreatic NET. No foci were detected by 111In-DTPA-OC SPECT (Precedence scanner). All findings on PET were confirmed to be true-positive. (A) 111In-DTPA-OC planar images. (B) 64Cu-DOTATATE maximum-intensity-projection image with arrows pointing at liver and lymph node metastases. Insert is fused PET/CT of peritoneal solitary tumor mass. (C) Axial CT and SPECT of liver. (D) Axial CT and PET of liver revealing several small liver metastases.

Conclusion: With these results, we demonstrate that 64Cu-DOTATATE is far superior to 111In-DTPA-OC in diagnostic performance in NET patients. Therefore, we do not hesitate to recommend implementation of 64Cu-DOTATATE as a replacement for 111In-DTPA-OC.

Any Clinical Trials Availability?

An expanded access program (EAP) is in place in a clinical trial setup.  Currently (at 14th July 2020) based at number of US locations – the status of this will be affected by the recent approval by US FDA on 4th September 2020 but am awaiting details.  

 
United States, Arizona
Banner MD Anderson Cancer CenterAvailable
Gilbert, Arizona, United States, 85234
United States, California
Mission Bay Hospital (University of California)Available
San Francisco, California, United States, 94158
Stanford Hospital and ClinicsAvailable
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer CentersAvailable
Denver, Colorado, United States, 80218
United States, Louisiana
Ochsner Clinic Foundation – KennerAvailable
Kenner, Louisiana, United States, 70065
United States, New York
Memorial Sloan Kettering Cancer CenterAvailable
New York, New York, United States, 10065
United States, Oregon
Oregon Health & Science UniversityAvailable
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical CenterAvailable
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Excel Diagnostics & Nuclear Oncology CenterAvailable
Houston, Texas, United States, 77042
United States, Wisconsin
University of Wisconsin School of Medicine and Public HealthAvailable
Madison, Wisconsin, United States, 53704

Summary

The shortage of Ga68 PET radionuclide caused by limitations of the generators in use is unfortunate. Reading the SNMMI letter, I think progress can be made downstream.  There is no news of any plans to extend this potential new radionuclide outside the US but I suspect that would change following the FDA approval.

If you can see it, you can detect it!

Thanks for reading

Ronny

I’m also active on Facebook. Like my page for even more news. Help me build up my new site here – click here and ‘Like’

Disclaimer

My Diagnosis and Treatment History

Sign up for my twitter newsletter

Check out my Podcast Interview (click and press play)

Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

Click picture above to enter the A to Z repository from Ronny Allan

wego-blog-2018-winner

patients included

Please Share this post for Neuroendocrine Cancer awareness and to help another patient

Share on facebook
Facebook
Share on twitter
Twitter
Share on pinterest
Pinterest
Share on whatsapp
WhatsApp
Share on email
Email

2 thoughts on “Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

I love comments - feel free!

%d bloggers like this: