radiolabeled albumin technetium Tc-99m albumin colloid kit
Trade name: Microlite
Approved
Feb 23, 1976
Technetium is a chemical element; it has symbol Tc and atomic number 43. It is the lightest element whose isotopes are all radioactive. Technetium and promethium are the only radioactive elements whose neighbours in the sense of atomic number are both stable. All available technetium is produced as a synthetic element. Naturally occurring technetium is a spontaneous fission product in uranium ore and thorium ore, or the product of neutron capture in molybdenum ores. This silvery gray, crystalline transition metal lies between manganese and rhenium in group 7 of the periodic table, and its chemical properties are intermediate between those of both adjacent elements. The most common naturally occurring isotope is 99Tc, in traces only. — Wikipedia
Clinical trial activity
7 trials · 9 clinical orgs · 10 marketing orgs
Earliest trial started Dec 1, 1998 (NCT00005821)
Timeline
1970s
- Feb 23, 1976
General Electric — Earliest FDA Approval
- Feb 23, 1976
Bracco — NDA Secondary Org
- Feb 23, 1976
General Electric — NDA Secondary Org
- Feb 23, 1976
Mallinckrodt — NDA Secondary Org
- Feb 23, 1976
General Electric — NDA Organization
- Nov 16, 1976
Jubilant DraxImage Inc. — NDA Secondary Org
- Jul 29, 1977
3M — NDA Secondary Org
1980s
- Mar 25, 1983
Pharmalucence — NDA Secondary Org
- Dec 30, 1987
Draximage — NDA Secondary Org
1990s
- Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
2020s
- Mar 20, 2020
CIS Bio International S.A. — Marketing Organization
- Mar 20, 2020
IBA — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Diagnostic agent
- Unspecified targetOTHER
Diagnostic
- Unspecified targetRadiopharmaceutical
Radiopharmaceutical
Approval history
- approvedFeb 23, 1976
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
- Imaging
- 99-technetium
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTechnetium ↗
- NCATS414JW8YPVE ↗
- ChEMBLCHEMBL1201412 ↗
- ChEMBLCHEMBL1201410 ↗
- ChEMBLCHEMBL2108890 ↗
- WikipediaTechnetium (99mTc) albumin aggregated ↗
- NCATSZ8E46IA45W ↗
- ChEMBLCHEMBL1201409 ↗
- ChEMBLCHEMBL1201522 ↗
Also known as
- 99mtc-albumin
- 99mtc albumin macroaggregates
- 99mtc human serum albumin colloid
- an-maa
- a-n stannous aggregated albumin
- instant microspheres
- instant microspheres
- lungaggregate reagent
- macrotec
- microlite
- microlite
- mp-4006
- pulmolite
- tc-99m albumin
- tc-99m human serum albumin (hsa)
- tc 99m-lungaggregate
- tc 99m-lungaggregate
- tc-99m mp-4006
- technescan maa
- technetium
- technetium
- technetium-99m macroaggregated albumin
- technetium tc 99m albumin
- technetium tc 99m albumin aggregated
- technetium tc-99m albumin aggregated
- technetium tc-99m albumin aggregated
- technetium tc-99m albumin aggregated
- technetium tc 99m albumin aggregated kit
- technetium tc-99m albumin aggregated kit
- technetium tc-99m albumin aggregated kit
- technetium tc 99m albumin colloid
- technetium tc-99m albumin colloid
- technetium tc-99m albumin colloid kit
- technetium tc-99m albumin colloid kit
- technetium tc-99m albumin kit
- technetium tc-99m albumin kit
- technetium tc-99m albumin microspheres kit
- technetium tc-99m albumin microspheres kit
- technetium tc-99m albumin microspheres kit
- technetium tc 99m hsa
- technetium tc 99m maa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02773238 | Phase 2 | May 1, 2016 | National Cancer Institute (NCI), University of Washington |
| NCT01982123 | N/A | Jan 1, 2014 | National Cancer Institute (NCI), University of Washington |
| NCT01495377 | Phase 4 | Jan 1, 2012 | Orebro University |
| NCT01049087 | N/A | Jan 1, 2012 | University Hospital Koge, University of Copenhagen |
| NCT01186263 | Phase 2 | Jul 1, 2010 | Sirtex Medical, University of Magdeburg |
| NCT00826280 | Phase 3 | Mar 1, 2009 | Astellas |
| NCT00005821 | Phase 2 | Dec 1, 1998 | Royal Marsden Hospital NHS Trust |
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 2 | 0 | 2 | 2014 |
| University of Washington | Academic/Hospital | 2 | 2 | 2 | 2014 |
| Astellas | For profit | 1 | 1 | 1 | 2009 |
| Orebro University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Royal Marsden Hospital NHS Trust | Academic/Hospital | 1 | 1 | 1 | 1998 |
| Sirtex Medical | For profit | 1 | 0 | 1 | 2010 |
| University Hospital Koge | Academic/Hospital | 1 | 0 | 1 | 2012 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2012 |
| University of Magdeburg | Academic/Hospital | 1 | 1 | 1 | 2010 |
Marketing (12)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| 3M | For profit | NDA2 | Jul 29, 1977 |
| Bracco | For profit | NDA2 | Feb 23, 1976 |
| CIS Bio International S.A. | For profit | MKTG | Mar 20, 2020 |
| Draximage | For profit | NDA2 | Dec 30, 1987 |
| General Electric | For profit | NDA2 | Feb 23, 1976 |
| General Electric | For profit | NDA | Feb 23, 1976 |
| IBA | For profit | NDA2 | Mar 20, 2020 |
| Jubilant DraxImage Inc. | For profit | SYN | Nov 16, 1976 |
| Jubilant DraxImage Inc. | For profit | NDA2 | Nov 16, 1976 |
| Mallinckrodt | For profit | NDA2 | Feb 23, 1976 |
| Pharmalucence | For profit | NDA2 | Mar 25, 1983 |
| Syncor International | For profit | NDA2 | — |