Table 1.
IDEAL framework and surgical outcomes
| Focus on lymph nodes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ref | Author (year) | IDEAL framework stage | Patients (patients treated with PSMA GS) | PSMA agent, administration, type of guidance | Type of surgery | Modality used | In or ex vivo | Total targets identified |
Sensitivity of surgical intervention | Specificity of surgical intervention | Metastasis size (mm) at histopathology | |||
| n (n) | PSMA PET/CT (/MRI) |
SPECT/CT | Intraoperatively/ex vivo | Tumor + at histopathology/total removed | % (95% CI) | % (95% CI) | Median (IQR) | |||||||
| [29] | Maurer (2015) | 1 | 5 | 111In-PSMA-I&T, IV, R | Open RP + ePLND sLND |
γ-probe declipse SPECT | In and ex vivo | 13 | – | 15 | 15/NR | NR | NR | 2.0–12.0 a |
| [33] | Rauscher (2017) | 2a | 31 |
111In-PSMA-I&T, IV, R |
Open sLND | γ-probe | In and ex vivo | NR | – | 54 FP = 6 FN = 4 |
52/145 | 92.3 (83.2–96.7) | 93.5 (81.7–97.9) | NR |
| [4] | Knipper (2019) | 2a | 42 (13) | 99mTc-PSMA-I&S, IV, R | Open sLND | γ-probe | In and ex vivo | 2.31b (1–6)a | NR | NR | 5b (1–15)a/range 2–53 | NR | NR | NR |
| [30] | Maurer (2018) | 2a | 31 | 99mTc-PSMA-I&S, IV, R | Open sLND | γ-probe | In and ex vivo | 44 | 25 | 46 FP = 0 FN = 12 |
58/132 | 83.6 (70.9–91.5) | 100 (–) | 12.0 (3.0–25.0) a |
| [31] | Mix (2018) | 2a | 6 | 111In-PSMA-617, IV, R | Open RP + ePLND sLND |
γ-probe HGD |
In and ex vivo | NR | NR | 35 FP = 2 FN = 3 |
38/318 single samples | 92.1 (–) | 98.8 (–) | NR |
| [24] | Horn (2019) | 2b | 121 | 111In-PSMA-I&T, 99mTc-PSMA-I&S, IV, R | Open sLND | γ-probe | In and ex vivo | 175 | NR | 180 | 214/median 11 | NR | NR | 3.0 (of regions) |
| [15] | Collamati (2020) | 1 | 7 | 68Ga-PSMA-11, IV, R | RA RP + ePLND | β-probe | Ex vivo | LNs: 4 | – | LNs: 4 FP = 1 |
LNs: 3/NR | NR | NR | Smallest identified node 7 mm |
| [25] | Jilg (2020) | 2 | 23 (21) | 111In-PSMA-617, IV, R | Open RP + ePLND sLND |
γ-probe HGD |
In and ex vivo | 87 | NR | γ-Probe: 72 HGD: 79 |
104/864 | γ-Probe: 62.1 (–) HGD: 71.2 (–) |
γ-Probe: 96.3 (–) HGD: 96.9 (–) |
NR |
| [32] | Mix (2021) | 1 | 6 | 99mTc-PSMA-I&S, IV, R | Open RP sLND |
γ-probe | In and ex vivo | NR | NR | 118 | 154/516 | 76.6 (0.69–0.83) | 94.0 (0.91–0.97) | NR |
| [17] | de Barros (2022) | 2a | 20 | 99mTc-PSMA-I&S, IV, R | RA sLND | γ-probe | In and ex vivo | 21 | 13 | 19 FN = 3 |
21/21 | 86.0 (–) | 100 (–) | 8.4 (3.9–15.0) |
| [19] | Gondoputro (2022) | 2a | 12 | 99mTc-PSMA-I&S, IV, R | RA RP + ePLND | γ-probe CT-guided hookwire |
In and ex vivo | 11 | 4 | 18 FP = 2 FN = 5 |
22/74 | In vivo 76.0 (53.0–92.0) Ex vivo 76.0 (53.0–92.0) |
In vivo 69.0 (55.0–81.0) Ex vivo 96.0 (87.0–99.0) |
9.0 (6.3–11.2) Smallest <1 mm |
| [27] | Knipper (2022) | 2b | 364 | 111In-PSMA-I&T, 99mTc-PSMA-I&S, IV, R | Open sLND | γ-probe | In and ex vivo | 364 | NR | 364 FP = 21 |
343/NR | NR | NR | NR |
| [23] | Yılmaz (2022) | 1 | 15 | 99mTc-PSMA-I&S, IV, R | RA RP + ePLND | γ-probe | In and ex vivo | NR | NR | 18 | 18/297 | 100 (–) | 100 (–) | NR |
| [18] | Gandaglia (2022) | 1 | 12 | 99mTc-PSMA-I&S, IV, R | RA RP + ePLND | γ-probe | In and ex vivo | 2 | 2 | 5 FP = 1 FN = 4 |
4/96 specimens | 50.0 | 99.0 | NR |
| [28] | Koehler (2023) | 1 | 9 |
99mTc-MIP-1404, IV, R |
Open sLND | γ-probe | In and ex vivo | 19 | 12 | 21 | 24/154 | 87.5 | 100.0 | 6 (2-4.5) |
| Case reports | ||||||||||||||
| [41] | Schottelius (2015) | 1 | 1 | 111In-PSMA-I&T, IV, R | Open sLND | γ-probe | In and ex vivo | NR | NR | NR | NR/NR | NR | NR | NR |
| [39] | Maurer (2016) | 1 | 1 | 111In-PSMA-I&T, IV, R | Open sLND | γ-probe | In and ex vivo | 1 | – | 1 | 1/NR | NR | NR | NR |
| [40] | Robu (2017) | 1 | 2 (1) | 99mTc-PSMA-I&S, IV, R | Open RP + ePLND | γ-probe | In and ex vivo | 1 | – | 1 | 1/NR | NR | NR | NR |
| [38] | Kratzik (2018) | 1 | 1 | 99mTc-PSMA-I&S, IV, R | Open sLND left sided | γ-probe | In and ex vivo | 1 | 1 | 1 | 1/NR | NR | NR | NR |
| [35] | Darr (2020) | 1 | 1 | 68Ga-PSMA-11, IV, O | Open sLND | CLI | Ex vivo | 1 | – | 1 | 2/17 | NR | NR | – |
| [42] | van Leeuwen (2019) | 1 | 1 | 99mTc-PSMA-I&S, IV, R | RA sLND | γ-probe | In and ex vivo | 1 | 1 | 1 | 1/NR | NR | NR | NR |
| [34] | Aras (2021) | 1 | 10 (2) | 18F-BF3-Cy3-ACUPA, IV, O | Open RP + ePLND | Solis 525C LED illuminator with CMOS camera | Ex vivo | NR | NR | 4 | 2/NR | NR | NR | NR |
| [37] | Erfani (2022) | 1 | 1 |
99mTc-PSMA IV, R |
Open sLND | γ-probe | In and ex vivo | 2 | 2 | 2 | 2/8 | NR | NR | NR |
| Author, year | Number of patients | PSMA agent, administration | Type of surgery | Modality used | Surgical margins | Sensitivity | Specificity | |||||||
| PSM intraoperatively/ex vivo | PSM at histopathology | % (95% CI) | % (95% CI) | |||||||||||
| Focus on prostate/local recurrence | ||||||||||||||
| [26] | Knipper (2021) | 2b | 40 | 111In-PSMA-I&T, 99mTc-PSMA-I&S, IV, R | Open sLND | γ-probe | In and ex vivo | NR | NR | NR | NR | NR | NR | NR |
| [22] | Darr (2020) | 1 | 10 | 68Ga-PSMA-11, IV, O | Open RP | CLI | Ex vivo | 2 | 3 | NR | NR | NA | ||
| [20] | olde Heuvel (2020) | 1 | 5 | 68Ga-PSMA-11, IV, O | RA RP | CLI | Ex vivo | 5 FP = 2 FN = 0 |
3 | NR | NR | NA | ||
| [21] | olde Heuvel (2022) | 1 | 15 | 68Ga-PSMA-11, IV, O | RA RP | CLI | Ex vivo | 6 hotspots FP = NR FN = 4 hotspots |
10 hotspots | NR | NR | NA | ||
| [16] | Darr (2021) | 1 | 7 | 68Ga-PSMA-11, IV, O | Open RP | CLI + 550 nm OF | Ex vivo | 3 | 3 | NR | NR | NA | ||
| Case reports | ||||||||||||||
| [36] | Eder (2021) | 1 | 1 | 68Ga-PSMA-914, IV, O | RA RP | NR | In and ex vivo | 1 | – | 1 | NR | NR | NR | NA |
CI =confidence interval; CLI = Cerenkov luminescence imaging; CMOS = complementary metal oxide semiconductor; CT = computed tomography; ePLND = extended pelvic lymph node dissection; FN = false negative; FP = false positive; Ga = gallium; HGD = high-purity germanium detector; IDEAL = Idea, Development, Exploration, Assessment, Long term; I&S = imaging and surgery; I&T = imaging and therapy; In = indium; IQR = interquartile range; IV = intravenous; LN = lymph node; MRI = magnetic resonance imaging; NA = not applicable; NR = not reported; O = optical guidance; OF = optical short-pass filter; PET = positron emission tomography; PSM = positive surgical margin; PSMA = prostate-specific membrane antigen; R = radioguidance; RA = robot assisted; RP = radical prostatectomy; SD = standard deviation; sLND = salvage lymph node dissection; SPECT = single photon emission computed tomography.
∼Maximum.
a
Range.
b
Mean (±SD).