Edit 21st January 2021. 

The imaging time window of 64Cu-DOTATATE positron emission tomography/computed tomography (PET/CT) for patients with neuroendocrine neoplasms can be expanded from one hour to three hours post-injection, according to new research published in the January 2021 issue of The Journal of Nuclear Medicine.  Read more here

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 Isotopen Technologien München AG (ITM) PRRT product currently in trial. I have written 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

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

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.  The scan is now authorised so it’s likely to be at least available in these locations but always check with your doctor first. 

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!